Inclusion Criteria:

- Patients with histologically confirmed HCC not suitable for OLT or resection ( > 3
nodules, >5 cm diameter, vascular invasion, clinically significant portal
hypertension, other contraindications against OLT)

- Child-Pugh Stage A or B

- Liver disease of any etiology

- Written informed consent (approved by the Institutional Review Board
[IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific
screening procedures

- Patient must be able to comply with the protocol

- Age ≥ 18 years

- Women of childbearing potential must have a negative serum pregnancy test done 1 week
prior to the administration of the Sorafenib.

Fertile women and men of childbearing potential ( < 2 years after last menstruation in
women) must use effective means of contraception (oral contraceptives, intrauterine
contraceptive device, barrier method of contraception in conjunction with spermicidal
jelly or surgically sterile)

- Haematology:

Absolute neutrophil count (ANC) > 1 x 109/L Platelet count > 40 x 109/L Haemoglobin > 9
g/dL (may be transfused to maintain or exceed this level) Prothrombin time ≥ 40%

- Biochemistry:

Total bilirubin < 5 mg/dL Serum creatinine < 3.0 mg/dL

- Life expectancy of > 3 months

Exclusion Criteria:

- Extrahepatic tumor spread

- Complete portal vein thrombosis (common trunk)

- Child-Pugh-Stage C

- Prior TACE or TAE

- Other experimental therapies for HCC

- Acute variceal bleeding within the last 2 weeks

- Large oesophageal varices ( > 5 mm diameter) without prophylactic band ligation

- Past or current history (within the last 2 years prior to randomisation) of
malignancies except for the indication under this study and curatively treated basal
and squamous cell carcinoma of the skin or in situ carcinoma of the cervix

- History or evidence upon physical examination of CNS disease unless adequately
treated (e.g., seizure not controlled with standard medical therapy or history of
stroke within < 6 months), excluding hepatic encephalopathy

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study treatment start, or anticipation of the need for major surgical
procedure during the course of the study

- Current or recent (within 10 days prior to study treatment start) use of full-dose
oral or parenteral anticoagulants for therapeutic purposes

- Chronic, daily treatment with aspirin (>325mg/day)

- Pregnancy (positive serum pregnancy test) or lactation

- Uncontrolled hypertension

- Serious, non-healing wound, ulcer, or bone fracture

- Currently or recent (within the 30 days prior to starting study treatment) treatment
of another investigational drug or participation in another investigational study

- Clinically significant (i.e. active) cardiovascular disease for example
cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction (
≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA)
grade II or greater congestive heart failure, serious cardiac arrhythmia requiring
medication

- Evidence of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates use of Sorafenib/TACE or patient at high risk from treatment
complications