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Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC
Not Recruiting
Trial ID: NCT00908752
Purpose
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
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)
Stanford Investigator(s)
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
John D. Louie, MD
Clinical Professor, Radiology
Eligibility
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
Intervention(s):
drug: Brivanib
procedure: TACE Therapy
other: Brivanib Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061