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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00908752

Acronym

BRISK TA

Enrollment

734

Registered

2009-05-27

Start date

2009-07-20

Completion date

2018-01-26

Last updated

2019-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

HCC

Brief summary

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.

Interventions

DRUGBrivanib

Tablets, Oral, 200 mg, once daily, until disease progression or toxicity

OTHERBrivanib Placebo

Tablets, Oral, 0 mg, once daily, until disease progression or toxicity

PROCEDURETACE Therapy

Trans-Arterial Chemo-Embolization Therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Argentina, Australia, Canada, China, France, Hong Kong, Italy, Japan, South Korea, Spain, Taiwan, Thailand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026