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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/NCT00855218
Registration number
NCT00855218
Ethics application status
Date submitted
3/03/2009
Date registered
4/03/2009
Date last updated
18/08/2017
Titles & IDs
Public title
A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).
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Scientific title
A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).
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Secondary ID [1]
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2008-005056-24
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Secondary ID [2]
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12918
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Universal Trial Number (UTN)
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Trial acronym
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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 - Sorafenib (Nexavar, BAY43-9006)
Treatment: Drugs - Placebo
Experimental: Sorafenib (Nexavar, BAY43-9006) + TACE - Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Patients were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
Placebo Comparator: Placebo + TACE - Placebo was to be orally administered as 2 tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
Treatment: Drugs: Sorafenib (Nexavar, BAY43-9006)
800 mg sorafenib (4 tablets) will be taken daily (400mg b.i.d. [twice daily], 2 tablets). Transarterial Chemoembolization (TACE) using DC Bead
Treatment: Drugs: Placebo
4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead
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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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Time to Progression (TTP) - Independent Radiological Review (Primary Analysis)
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Assessment method [1]
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TTP is defined as the time (days) from randomization to radiological confirmed disease progression. Participants without progression at the time of analysis were censored at their last date of tumor evaluation.
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Timepoint [1]
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From randomization of the first participant until 28 months later (cut-off date)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall Survival (OS) was defined as the time (days) from randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last date of last contact.
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Timepoint [1]
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From randomization of the first participant until 28 months later (cut-off date)
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Secondary outcome [2]
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Time to Untreatable Progression (TTUP)
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Assessment method [2]
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Time to untreatable progression (TTUP) was defined as the time (days) from randomization to untreatable progression. Participants without untreatable progression at the time of analysis were censored at their last date of tumor evaluation.
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Timepoint [2]
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From randomization of the first participant until 28 months later (cut-off date)
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Secondary outcome [3]
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Time to Vascular Invasion/Extrahepatic Spread (TTVI/ES)
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Assessment method [3]
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Time to vascular invasion/extrahepatic spread (TTVI/ES) was defined as the time (days) from randomization to vascular invasion/extrahepatic spread. Participants without vascular invasion/extrahepatic spread at the time of analysis were censored at their last date of tumor evaluation.
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Timepoint [3]
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From randomization of the first participant until 28 months later (cut-off date)
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Secondary outcome [4]
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Tumor Response - Independent Radiological Review
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Assessment method [4]
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Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
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Timepoint [4]
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From randomization of the first participant until 28 months later (cut-off date)
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Secondary outcome [5]
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Tumor Response - Investigator Assessment
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Assessment method [5]
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Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
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Timepoint [5]
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From randomization of the first participant until 28 months later (cut-off date)
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Eligibility
Key inclusion criteria
- Unresectable, multinodular asymptomatic tumor without vascular invasion or
extrahepatic spread
- Confirmed Diagnosis of HCC:
- Cirrhotic subjects: Clinical diagnosis by American Association for the Study of Liver
Diseases (AASLD) criteria
- HCC can be defined in cirrhotic subjects by one imaging technique (Computed tomography
[CT] scan, Magnetic resonance imaging [MRI], or second generation contrast ultrasound)
showing a nodule larger than 2 cm with contrast uptake in the arterial phase and
washout in venous or late phases or two imaging techniques showing this radiological
behavior for nodules of 1-2 cm in diameter.
- Cytohistological confirmation is required for subjects who do not fulfill these
eligibility criteria.
- Non-cirrhotic subjects:
For subjects without cirrhosis, histological or cytological confirmation is mandatory
- Documentation of original biopsy for diagnosis is acceptable
- Child Pugh class A without ascites
- Adequate bone marrow, liver and renal function as assessed by central lab by means of
the following laboratory requirements from samples within 7 days prior to
randomization:
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Minimum age
18
Years
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Maximum age
No limit
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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
- Patients on a liver transplantation list or with advanced liver disease as defined
below:
- Child Pugh B and C
- Active gastrointestinal bleeding
- Encephalopathy
- Ascites
- Lesions having previously been treated with local therapy such as resection of HCC,
radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation
can not be selected as the target lesions.
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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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
1/03/2009
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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
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Actual
1/02/2013
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Sample size
Target
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Accrual to date
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Final
307
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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- Camperdown
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Recruitment hospital [2]
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- St Leonards
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- Greenslopes
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Recruitment hospital [4]
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- Clayton
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Recruitment hospital [5]
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- Heidelberg
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Recruitment hospital [6]
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- Melbourne
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Recruitment hospital [7]
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- Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4120 - Greenslopes
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment postcode(s) [6]
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3004 - Melbourne
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Florida
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United States of America
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Georgia
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Washington
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Austria
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Innsbruck
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Austria
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Wien
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Bruxelles - Brussel
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Leuven
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Ontario
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China
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Guangdong
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China
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Shannxi
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China
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Beijing
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China
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Creteil
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Lille
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Hessen
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Lazio
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Italy
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Italy
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Piemonte
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Italy
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Italy
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Italy
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Korea, Republic of
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Daegu
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Singapore
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A Coruña
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Asturias
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Barcelona
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Bilbao
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Catalunya
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Madrid
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Santa Cruz de Tenerife
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Spain
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Alicante
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Spain
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Córdoba
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Sevilla
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Valencia
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Taiwan
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Changhua
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will look at whether our drug (sorafenib) in combination with chemotherapy
delivered directly into your tumor using beads (DC Bead) will slow the progression of the
disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing
the adverse effects that normally occur with chemotherapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00855218
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bayer Study Director
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Address
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Bayer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00855218
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