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

Status:	Completed
Conditions:	Liver Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/17/2018
Start Date:	July 20, 2009
End Date:	January 26, 2018

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)

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.

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

We found this trial at

sites

University of Texas M.D. Anderson Cancer Center

1515 Holcombe Blvd
Houston, Texas 77030

713-792-2121