Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Brivanib
* Other: Brivanib Placebo
* Procedure: TACE Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brivanib<br>Adjuvant treatment with TACE Therapy | Drug: Brivanib<br>* Tablets, Oral, 200 mg, once daily, until disease progression or toxicity<br>* Other names: BMS-582664;Procedure: TACE Therapy<br>* Trans-Arterial Chemo-Embolization Therapy<br>|
| Placebo Comparator: Brivanib Placebo<br>Placebo adjuvant treatment with TACE Therapy | Other: Brivanib Placebo<br>* Tablets, Oral, 0 mg, once daily, until disease progression or toxicity<br>Procedure: TACE Therapy<br>* Trans-Arterial Chemo-Embolization Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Survival will be assessed continuously | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy |  | Every 8 weeks | 
| To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms |  | Every 8 weeks | 
| To determine the total number of TACE sessions in the brivanib and placebo arms and to compare the rate of TACE sessions in the brivanib and placebo arms |  | End of Study | 
| To evaluate the safety of brivanib in combination with TACE |  | Every 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC