Clinical trial · Interventional
Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC
A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)
NCT00908752CI-TRIAL-00042017BRISK TAcompletedPhase 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 (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE 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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brivanib | Drug | — | UNRESOLVED |
| Brivanib Placebo | Other | — | UNRESOLVED |
| TACE Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Brivanib
- description
- Adjuvant treatment with TACE Therapy
- interventionNames
- Drug: Brivanib
- Procedure: TACE Therapy
- type
- PLACEBO_COMPARATOR
- label
- Brivanib Placebo
- description
- Placebo adjuvant treatment with TACE Therapy
- interventionNames
- Other: Brivanib Placebo
- Procedure: TACE Therapy
Primary outcomes (1)
- measure
- To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy
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: * Patients with diagnosis of hepatocellular carcinoma * Cirrhotic status of Child-Pugh Class A or B with a score of 7 * ECOG performance status of 0 or 1 * Adequate hematologic, hepatic, and renal function Exclusion criteria: * Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC * History of cardiac disease * Active and untreated hepatitis B * Inability to swallow tablets or untreated malabsorption syndrome * History of human immunodeficiency virus (HIV) infection
References
Publications (0)
Data not yet available
No reference posted for this study.