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)

John D. Louie, MD
John D. Louie, MD

Clinical Professor, Radiology

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine

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

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