Inclusion Criteria

Inclusion criteria:

- Subjects with histologically or cytologically or clinically diagnosed advanced HCC
not amenable to surgical or local treatment. Documentation of original pathology for
diagnosis is acceptable if tumor tissue is unavailable at screening.

- Signed written informed consent

Exclusion criteria:

- Clinically diagnosed subjects who did not meet two following criteria:

- cirrhotic patients with focal lesion > 2cm with arterial hypervascularization
demonstrated by 2 coincident imaging techniques

- cirrhotic patients with focal lesion > 2cm with arterial hypervascularization
demonstrated by 1 imaging technique and associated with Alpha Fetoprotein (AFP)
level > 400 ng/mL

- Subjects who are receiving or previously received any other investigational therapy
or any other systemic anti-cancer treatment for HCC including chemotherapy,
immunotherapy or targeted agents, except radiotherapy to non-target lesion (bone
metastasis, etc) and HCC adjuvant therapy which was completed more than 6 months
prior to randomization. Antiviral treatment is allowed, however interferon therapy
must be stopped at least 4 weeks prior to randomization.

- Subjects with main portal vein thrombosis.

- Subjects with encephalopathy or history of encephalopathy, ascites uncontrolled by
medication, active or history of variceal or gastrointestinal bleeding within 30 days

- Subjects with Central Nervous System (CNS) metastasis

- Subjects without one target tumor lesion that be measurable at baseline according to
Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria

- Subjects who have received local therapy such as surgery, hepatic arterial therapy,
chemoembolization, radiofrequency ablation, percutaneous ethanol injection within 4
weeks prior to randomization

- Subjects with Child-Pugh > A

- Eastern Cooperative Oncology Group (ECOG) > 2

- Subjects with inadequate bone marrow, liver and renal function

- Subjects with previous liver transplantation

- Subjects with other serious diseases or medical conditions within 6 months that might
be associated with a life expectancy of less than 3 months

- Subjects with other malignant disease previously or concurrently, except cured basal
cell carcinoma of skin, cervical carcinoma in situ or any cancer curatively treated >
3 years prior to study entry

- Subjects with known severe hypersensitivity to sorafenib or any other component of
sorafenib

- Pregnant or lactating women, or women of child bearing potential without
contraceptive method or unwilling to take effective contraception during the study

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.