A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC

A Multicenter, Randomized, Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of Brivanib Alaninate (ZL-2301) Combined With Best Supportive Care (BSC) and Pharmacokinetic Profiles of Brivanib Alaninate in Patients With Advanced Hepatocellular Carcinoma (HCC) Failed or Intolerant of Standard Systemic Chemotherapy and/or Sorafenib

This is a Phase 2, Open-label, Randomized, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Brivanib in Patients with Previously Treated Advanced Hepatocellular Carcinoma.

Inclusion Criteria:

• 18-75 years, male or female
• Histologically or cytologically confirmed or the clinical diagnosis standard confirmed hepatocellular carcinoma (HCC) patients
• Failure or intolerance to prior treatment with chemotherapy and/or targeted therapy
• Liver function status Child-Pugh Class A or B (score≤7)
• ECOG Performance Status score 0 or 1
• Patients must have adequate bone marrow, renal and hepatic function

Exclusion Criteria:

• Known history or symptomatic metastatic brain
• Uncontrolled moderate and severe ascites
• With bleeding tendency and thrombosis history
• Known history of severe cardiovascular disease
• Uncontrollable active infections (≥CTCAE Grade 2)
• Pregnant or breastfeeding women