Study in Asia of the Combination of TACE With Sorafenib in HCC Patients

Inclusion Criteria: * Age ≧ 18 * life expectancy \> 12 weeks * Histologically diagnosed HCC, OR clinically diagnosed HCC for patients with difficulty in obtaining histological diagnosis. A clinically diagnosed HCC should fulfill ALL the criteria below * Chronic hepatitis B or C and/or evidence of liver cirrhosis. * Presence of hepatic tumour(s) with image findings compatible with HCC, and no evidence of other gastrointestinal tumours * A persistent elevation of serum AFP \>= 400 ng/ml without any evidence of an existing α-fetoprotein-secreting germ cell tumour * Child-Pugh score ≦ 7 * BCLC B * The patient must have a solitary hepatic tumour greater than 3 cm in diameter or multifocal disease as evidenced by CT or MRI scanning. * The target lesion must not have been previously treated with local therapy * The patient must not be a candidate for surgical resection or ablation of the tumour. Size of largest tumor ≦10cm in largest dimension * Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) to non-target lesions are eligible * Local therapy must have been completed at least 4 weeks prior to baseline scan. * ECOG performance status 0 or 1 * Hb ≧ 9g/dL, * Absolute neutrophil count \> 1000/mm3 * Platelet count ≧ 60x109/L * Adequate clotting function: INR \< 1.5 * Hepatic: AST or ALT \< 5 X ULN * Renal: serum creatinine \< 1.5 x ULN * Bilirubin ≦ 3mg/dL * The patient must give written, informed consent Exclusion Criteria: * Tumor factors * Presence of extrahepatic metastasis * Predominantly infiltrative lesion * Diffuse tumor morphology with extensive lesions involving both lobes. * Vascular complications * Hepatic artery thrombosis, or * Partial or complete thrombosis of the main portal vein, or * Tumor invasion of portal branch of contralateral lobe, or * Hepatic vein tumor thrombus, or * Significant arterioportal shunt not amenable to shunt blockage * Liver function * Advanced liver disease: ascites, hepatic encephalopathy * Patients with clinically significant gastrointestinal bleeding within the 30 days prior to study entry. * Others * Pregnant or lactating women. * Active sepsis or bleeding. * Hypersensitivity to intravenous contrast agents. * The patient has received prior treatment for HCC target lesion. * History of cardiac disease * Congestive heart failure \> NYHA class 2; active coronary artery disease * Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin. * Hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management. * Therapeutic anticoagulation with coumarin, heparins, or heparinoids. * Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months. * Impairment of swallowing that would preclude administration of sorafenib. * The patient is, in the opinion of the investigator, unable and / or unwilling to comply with treatment and study instructions. * 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 * Any active clinically serious infections (\> grade 2 NCI-CTCAE ver 3.0) * HIV infection or AIDS-related illness or serious acute or chronic illness (based on medical history)