A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).

Inclusion Criteria

• Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread
• Confirmed Diagnosis of HCC:
• Cirrhotic subjects: Clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria
• HCC can be defined in cirrhotic subjects by one imaging technique (Computed tomography [CT] scan, Magnetic resonance imaging [MRI], or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.
• Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
• Non-cirrhotic subjects:

For subjects without cirrhosis, histological or cytological confirmation is mandatory

• Documentation of original biopsy for diagnosis is acceptable
• Child Pugh class A without ascites
• Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:

Exclusion Criteria

• Patients on a liver transplantation list or with advanced liver disease as defined below:
• Child Pugh B and C
• Active gastrointestinal bleeding
• Encephalopathy
• Ascites
• Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.