Clinical trial · Interventional
First Line Hepato Cellular Carcinoma (HCC)
A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT00858871CI-TRIAL-00024317BRISK FLcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepato Cellular Carcinoma (HCC) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brivanib | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Brivanib
- interventionNames
- Drug: Brivanib
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib
- interventionNames
- Drug: Sorafenib
- Drug: Placebo
Primary outcomes (1)
- measure
- To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment
- timeFrame
- Survival will be assessed continuously
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDKolamunnage-Dona R, Berhane S, Potts H, Williams EH, Tanner J, Janowitz T, Hoare M, Johnson P. Sorafenib is associated with a reduced rate of tumour growth and liver function deterioration in HCV-induced hepatocellular carcinoma. J Hepatol. 2021 Oct;75(4):879-887. doi: 10.1016/j.jhep.2021.05.015. Epub 2021 May 27. PMID 34052255
- DERIVEDJohnson PJ, Qin S, Park JW, Poon RT, Raoul JL, Philip PA, Hsu CH, Hu TH, Heo J, Xu J, Lu L, Chao Y, Boucher E, Han KH, Paik SW, Robles-Avina J, Kudo M, Yan L, Sobhonslidsuk A, Komov D, Decaens T, Tak WY, Jeng LB, Liu D, Ezzeddine R, Walters I, Cheng AL. Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: results from the randomized phase III BRISK-FL study. J Clin Oncol. 2013 Oct 1;31(28):3517-24. doi: 10.1200/JCO.2012.48.4410. Epub 2013 Aug 26. PMID 23980084