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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03434379
Registration number
NCT03434379
Ethics application status
Date submitted
31/01/2018
Date registered
15/02/2018
Date last updated
23/10/2023
Titles & IDs
Public title
A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
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Scientific title
A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
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Secondary ID [1]
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2017-003691-31
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Secondary ID [2]
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YO40245
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Universal Trial Number (UTN)
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Trial acronym
IMbrave150
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Hepatocellular
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Liver
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Sorafenib
Experimental: Atezolizumab + Bevacizumab - Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator
Active Comparator: Sorafenib - Participants will receive Sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator
Treatment: Drugs: Atezolizumab
Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle
Treatment: Drugs: Bevacizumab
Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle
Treatment: Drugs: Sorafenib
Sorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS) in the Global Population
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Assessment method [1]
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OS was defined as the time from randomization to death from any cause.
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Timepoint [1]
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From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)
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Primary outcome [2]
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Progression Free Survival by Independent Review Facility-Assessment (PFS-IRF) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the Global Population
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Assessment method [2]
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PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
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Timepoint [2]
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Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Primary outcome [3]
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Overall Survival (OS) in the China Population
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Assessment method [3]
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OS was defined as the time from randomization to death from any cause.
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Timepoint [3]
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From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)
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Primary outcome [4]
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PFS-IRF Per RECIST v1.1 in the China Population
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Assessment method [4]
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PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
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Timepoint [4]
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Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [1]
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Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the Global Population
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Assessment method [1]
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ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
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Timepoint [1]
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Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [2]
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Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the Global Population
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Assessment method [2]
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ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
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Timepoint [2]
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Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [3]
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ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the Global Population
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Assessment method [3]
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ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
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Timepoint [3]
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Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [4]
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Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the Global Population
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Assessment method [4]
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DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.
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Timepoint [4]
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Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [5]
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Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population
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Assessment method [5]
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DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.
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Timepoint [5]
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Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [6]
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Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the Global Population
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Assessment method [6]
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DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.
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Timepoint [6]
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Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [7]
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PFS-IRF Per HCC mRECIST in the Global Population
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Assessment method [7]
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PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
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Timepoint [7]
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Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [8]
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PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the Global Population
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Assessment method [8]
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PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
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Timepoint [8]
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Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [9]
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Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the Global Population
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Assessment method [9]
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Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
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Timepoint [9]
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Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [10]
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TTP-IRF Per HCC mRECIST in the Global Population
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Assessment method [10]
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Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
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Timepoint [10]
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Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [11]
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TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the Global Population
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Assessment method [11]
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Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
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Timepoint [11]
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Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [12]
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Overall Survival by Baseline AFP in the Global Population
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Assessment method [12]
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OS was defined as the time from randomization to death from any cause. Subpopulations with baseline AFP <400 ng/mL and AFP>/= 400 ng/mL were analyzed.
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Timepoint [12]
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From randomization to death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [13]
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PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population
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Assessment method [13]
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PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm). Subpopulations with baseline AFP <400 ng/mL and AFP>/= 400 ng/mL were analyzed.
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Timepoint [13]
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0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [14]
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PFS-INV Per RECIST v1.1 by Baseline AFP in the Global Population
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Assessment method [14]
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0
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm). Subpopulations with baseline AFP <400 ng/mL and AFP>/= 400 ng/mL were analyzed.
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Timepoint [14]
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0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [15]
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Time to Deterioration (TTD) in the Global Population
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Assessment method [15]
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TTD was defined as the time from randomization to the first deterioration (decrease from baseline of >/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.
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Timepoint [15]
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0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [16]
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Number of Participants With Adverse Events (AEs) in the Global Population
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Assessment method [16]
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An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
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Timepoint [16]
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Up to end of study (up to approximately 56 months)
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Secondary outcome [17]
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Maximum Serum Concentration (Cmax) of Atezolizumab at Cycle 1 in the Global Population
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Assessment method [17]
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0
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Timepoint [17]
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Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)
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Secondary outcome [18]
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Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
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Assessment method [18]
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Timepoint [18]
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Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)
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Secondary outcome [19]
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Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the Global Population
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Assessment method [19]
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Timepoint [19]
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Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 30 months)
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Secondary outcome [20]
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Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the China Population
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Assessment method [20]
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ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
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Timepoint [20]
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0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [21]
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0
Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the China Population
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Assessment method [21]
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ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
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Timepoint [21]
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0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [22]
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0
ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the China Population
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Assessment method [22]
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ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
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Timepoint [22]
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0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [23]
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0
Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population
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Assessment method [23]
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DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.
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Timepoint [23]
0
0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [24]
0
0
Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the China Population
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Assessment method [24]
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0
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.
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Timepoint [24]
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0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [25]
0
0
Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the China Population
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Assessment method [25]
0
0
DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.
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Timepoint [25]
0
0
Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [26]
0
0
PFS-IRF Per HCC mRECIST in the China Population
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Assessment method [26]
0
0
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
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Timepoint [26]
0
0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [27]
0
0
PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the China Population
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Assessment method [27]
0
0
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
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Timepoint [27]
0
0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [28]
0
0
Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the China Population
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Assessment method [28]
0
0
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
Query!
Timepoint [28]
0
0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [29]
0
0
TTP-IRF Per HCC mRECIST in the China Population
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Assessment method [29]
0
0
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
Query!
Timepoint [29]
0
0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [30]
0
0
TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the China Population
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Assessment method [30]
0
0
Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
Query!
Timepoint [30]
0
0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [31]
0
0
Time to Deterioration (TTD) in the China Population
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Assessment method [31]
0
0
TTD was defined as the time from randomization to the first deterioration (decrease from baseline of >/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.
Query!
Timepoint [31]
0
0
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
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Secondary outcome [32]
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0
Number of Participants With Adverse Events (AEs) in the China Population
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Assessment method [32]
0
0
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Query!
Timepoint [32]
0
0
Up to end of study (up to approximately 56 months)
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Secondary outcome [33]
0
0
Maximum Serum Concentration (Cmax) of Atezolizumab in the China Population
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Assessment method [33]
0
0
Query!
Timepoint [33]
0
0
Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)
Query!
Secondary outcome [34]
0
0
Trough Serum Concentration (Cmin) of Atezolizumab in the China Population
Query!
Assessment method [34]
0
0
Query!
Timepoint [34]
0
0
Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)
Query!
Secondary outcome [35]
0
0
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the China Population
Query!
Assessment method [35]
0
0
Query!
Timepoint [35]
0
0
Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 18 months)
Query!
Eligibility
Key inclusion criteria
- Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
- No prior systemic therapy for HCC. Previous use of herbal therapies/traditional
Chinese medicines with anti-cancer activity included in the label is allowed, provided
that these medications are discontinued prior to randomization.
- At least one measurable untreated lesion
- ECOG Performance Status of 0 or 1
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent
- For men: agreement to remain abstinent
- Child-Pugh class A
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest computed tomography scan
- Known active tuberculosis
- History of malignancy other than HCC within 5 years prior to screening, with the
exception of malignancies with a negligible risk of metastasis or death
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment
or within at least 5 months after the last dose of atezolizumab, 6 months after the
last dose of bevacizumab, or 1 month after the last dose of sorafenib
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or
high-risk for bleeding
- A prior bleeding event due to esophageal and/or gastric varices within 6 months prior
to initiation of study treatment.
- Moderate or severe ascites
- History of hepatic encephalopathy
- Co-infection of HBV and HCV
- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures
- Uncontrolled or symptomatic hypercalcemia
- Treatment with systemic immunostimulatory agents
- Inadequately controlled arterial hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- Evidence of bleeding diathesis or significant coagulopathy
- History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction
including sub-occlusive disease related to the underlying disease or requirement for
routine parenteral hydration
- Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
- Metastatic disease that involves major airways or blood vessels, or centrally located
mediastinal tumor masses
- Local therapy to liver within 28 days prior to initiation of study treatment or
non-recovery from side effects of any such procedure
- Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/03/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
17/11/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
558
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
Bankstown-Lidcombe Hospital - Bankstown
Query!
Recruitment hospital [2]
0
0
St George Hospital - Kogarah
Query!
Recruitment hospital [3]
0
0
The Queen Elizabeth Hospital - Woodville
Query!
Recruitment hospital [4]
0
0
Sunshine Hospital - St Albans
Query!
Recruitment postcode(s) [1]
0
0
2200 - Bankstown
Query!
Recruitment postcode(s) [2]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [3]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [4]
0
0
3021 - St Albans
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Massachusetts
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Michigan
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New Mexico
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Pennsylvania
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Washington
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Ontario
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Quebec
Query!
Country [16]
0
0
China
Query!
State/province [16]
0
0
Beijing City
Query!
Country [17]
0
0
China
Query!
State/province [17]
0
0
Beijing
Query!
Country [18]
0
0
China
Query!
State/province [18]
0
0
Changchun
Query!
Country [19]
0
0
China
Query!
State/province [19]
0
0
Changsha CITY
Query!
Country [20]
0
0
China
Query!
State/province [20]
0
0
Foshan
Query!
Country [21]
0
0
China
Query!
State/province [21]
0
0
Fuzhou
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Guangzhou City
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Guangzhou
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Hangzhou City
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Hangzhou
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Harbin
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Hefei City
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Hefei
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Jinan
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Nanjing City
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Shanghai City
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Shanghai
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Wuhan
Query!
Country [34]
0
0
Czechia
Query!
State/province [34]
0
0
Brno
Query!
Country [35]
0
0
Czechia
Query!
State/province [35]
0
0
Olomouc
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Lille
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Lyon
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Marseille
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Montpellier
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Nantes
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Nice Cedex
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Rouen
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Strasbourg
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Vandoeuvre-les-nancy
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Villejuif
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Berlin
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Frankfurt
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Hamburg
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Hannover
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Leipzig
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Mainz
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Regensburg
Query!
Country [53]
0
0
Hong Kong
Query!
State/province [53]
0
0
Hong Kong
Query!
Country [54]
0
0
Hong Kong
Query!
State/province [54]
0
0
Shatin
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Campania
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Emilia-Romagna
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Piemonte
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Sardegna
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Toscana
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Veneto
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Chiba
Query!
Country [62]
0
0
Japan
Query!
State/province [62]
0
0
Fukuoka
Query!
Country [63]
0
0
Japan
Query!
State/province [63]
0
0
Hokkaido
Query!
Country [64]
0
0
Japan
Query!
State/province [64]
0
0
Ishikawa
Query!
Country [65]
0
0
Japan
Query!
State/province [65]
0
0
Kanagawa
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Kumamoto
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Osaka
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Saga
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Shizuoka
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Tokyo
Query!
Country [71]
0
0
Korea, Republic of
Query!
State/province [71]
0
0
Jeollanam-do
Query!
Country [72]
0
0
Korea, Republic of
Query!
State/province [72]
0
0
Seoul
Query!
Country [73]
0
0
Korea, Republic of
Query!
State/province [73]
0
0
Ulsan
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Gdansk
Query!
Country [75]
0
0
Poland
Query!
State/province [75]
0
0
Myslowice
Query!
Country [76]
0
0
Poland
Query!
State/province [76]
0
0
Olsztyn
Query!
Country [77]
0
0
Poland
Query!
State/province [77]
0
0
Warszawa
Query!
Country [78]
0
0
Poland
Query!
State/province [78]
0
0
Wroc?aw
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
Moskovskaja Oblast
Query!
Country [80]
0
0
Russian Federation
Query!
State/province [80]
0
0
Sankt Petersburg
Query!
Country [81]
0
0
Singapore
Query!
State/province [81]
0
0
Singapore
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Barcelona
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Madrid
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Zaragoza
Query!
Country [85]
0
0
Taiwan
Query!
State/province [85]
0
0
Tainan
Query!
Country [86]
0
0
Taiwan
Query!
State/province [86]
0
0
Taipei
Query!
Country [87]
0
0
Taiwan
Query!
State/province [87]
0
0
Taoyuan County
Query!
Country [88]
0
0
United Kingdom
Query!
State/province [88]
0
0
Glasgow
Query!
Country [89]
0
0
United Kingdom
Query!
State/province [89]
0
0
London
Query!
Country [90]
0
0
United Kingdom
Query!
State/province [90]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will evaluate the efficacy and safety of atezolizumab in combination with
bevacizumab compared with sorafenib in participants with locally advanced or metastatic
Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03434379
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03434379
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