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

• Status: Completed
• Trial end date: 2018-01-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

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