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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03778957
Registration number
NCT03778957
Ethics application status
Date submitted
28/11/2018
Date registered
19/12/2018
Titles & IDs
Public title
A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
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Scientific title
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)
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Secondary ID [1]
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2018-002134-20
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Secondary ID [2]
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D933GC00001
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Universal Trial Number (UTN)
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Trial acronym
EMERALD-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma
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Condition category
Condition code
Cancer
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0
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0
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Non melanoma skin cancer
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Cancer
0
0
0
0
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Kidney
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Cancer
0
0
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0
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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 - Durvalumab
Treatment: Drugs - Bevacizumab
Other interventions - Placebo
Treatment: Surgery - Transarterial Chemoembolization (TACE)
Experimental: Arm A - Transarterial Chemoembolization (TACE) in combination with Durvalumab
Experimental: Arm B - Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
Placebo comparator: Arm C - Transarterial Chemoembolization (TACE) in combination with Placebos
Treatment: Drugs: Durvalumab
Durvalumab IV (intravenous)
Treatment: Drugs: Bevacizumab
Bevacizumab IV (intravenous)
Other interventions: Placebo
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)
Treatment: Surgery: Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Intervention code [3]
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Treatment: Surgery
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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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Progression Free Survival (PFS) for Arm B vs Arm C
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Assessment method [1]
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PFS per Blinded Independent Central Review (BICR) assessment will be defined as the time from the date of randomization until the date of first objective disease progression or death
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Timepoint [1]
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Approximately 5 years
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Secondary outcome [1]
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Progression Free Survival (PFS) for Arm A vs Arm C
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Assessment method [1]
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PFS per Blinded Independent Central Review (BICR) assessment will be defined as the time from the date of randomization until the date of first objective disease progression or death
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Timepoint [1]
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Approximately 5 years
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from the date of randomization until death due to any cause
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Timepoint [2]
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Approximately 5 years
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Secondary outcome [3]
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Health status/quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30)
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Assessment method [3]
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Collection of patient reported outcome (PRO) measures to assess time to deterioration in global health status/quality of life (QoL), functioning (physical) and symptoms
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Timepoint [3]
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Approximately 5 years
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Secondary outcome [4]
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Disease-related symptoms measured by European Organization for Research and Treatment of Cancer (EORTC) 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18)
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Assessment method [4]
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Collection of patient reported outcome (PRO) measures to assess time to deterioration in symptoms
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Timepoint [4]
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Approximately 5 years
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Eligibility
Key inclusion criteria
Key
* No evidence of extrahepatic disease
* Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
* Child-Pugh score class A to B7 and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
* Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
* Adequate organ and marrow function
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Minimum age
18
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Maximum age
110
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
* Any history of nephrotic or nephritic syndrome
* Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization
* Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion)
* History of abdominal fistula or GI perforation, non healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
* Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/08/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
724
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Recruitment in Australia
Recruitment state(s)
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Research Site - Benowa
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Research Site - Box Hill
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4217 - Benowa
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Recruitment postcode(s) [2]
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3128 - Box Hill
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2050 - Camperdown
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3168 - Clayton
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4029 - Herston
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2170 - Liverpool
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Recruitment postcode(s) [7]
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3004 - Melbourne
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Taichung
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Taiwan
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State/province [125]
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Tainan City
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Country [126]
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Taiwan
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Taipei
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Country [127]
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Taiwan
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Taoyuan City
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Hat Yai
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Thailand
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Khon Kaen
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Thailand
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Phisanulok
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Vietnam
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Hanoi
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Vietnam
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Ho Chi Minh City
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Vietnam
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
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Summary
Brief summary
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
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Trial website
https://clinicaltrials.gov/study/NCT03778957
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Trial related presentations / publications
Kloeckner R, Galle PR, Bruix J. Local and Regional Therapies for Hepatocellular Carcinoma. Hepatology. 2021 Jan;73 Suppl 1:137-149. doi: 10.1002/hep.31424. Epub 2020 Nov 6. No abstract available.
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Public notes
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Contacts
Principal investigator
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Bruno Sangro, MD
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Clinica Universidad de Navarra
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03778957