First Line Hepato Cellular Carcinoma (HCC) (BRISK FL)
Status and phase
Completed
Phase 3
Conditions
Hepato Cellular Carcinoma (HCC)
Treatments
Drug: Sorafenib
Drug: Brivanib
Drug: Placebo
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.
Enrollment
1,714 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
- Histologic or cytologic confirmed diagnosis of HCC.
- Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies
- Child-Pugh Class A
- ECOG performance status 0-1
- Adequate hematologic, hepatic, and renal function
Exclusion Criteria:
- Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC
- History of active cardiac disease
- Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)
- Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices
- Inability to swallow tablets or untreated malabsorption syndrome
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
1,714 participants in 2 patient groups
Brivanib
Active Comparator group
Treatment:
Drug: Brivanib
Drug: Placebo
Drug: Placebo
Sorafenib
Active Comparator group
Treatment:
Drug: Sorafenib
Drug: Placebo
Drug: Placebo
Trial contacts and locations
173
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Data sourced from clinicaltrials.gov
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