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.