The purpose of this phase III, randomized, placebo-controlled study is to evaluate the safety and efficacy of sorafenib versus placebo in patients with advanced hepatocellular carcinoma (HCC).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients who have a life expectancy of at least 12 weeks.
• Patients with histologically or cytologically documented HCC.
• Patients must have at least one tumor lesion that meets both of the following criteria: (1) Accurately measured in at least one dimension according to RECIST (2) Not previously treated with local therapy
• Patients who have an ECOG PS of 0, 1, or 2.

Exclusion Criteria:

• Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted.
• Renal failure requiring hemo- or peritoneal dialysis.
• History of cardiac disease.
• Active clinically serious infections.
• Known history of human immunodeficiency virus (HIV) infection.
• Known central nervous system tumors including metastatic brain disease.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Other inclusion/exclusion criteria may apply.