A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Inclusion Criteria:

- Histologic or cytologic confirmed diagnosis of HCC.

- Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR
progressive disease after surgical and/or locoregional therapies

- Child-Pugh Class A

- ECOG performance status 0-1

- Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

- Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular
targeted agents for HCC

- History of active cardiac disease

- Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)

- Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for
esophageal or gastric varices

- Inability to swallow tablets or untreated malabsorption syndrome