Combination of Transcatheter Arterial Chemoembolization (TACE) and Sorafenib for Patients With Unresectable Hepatocellular Carcinoma (HCC)

Inclusion Criteria: * Patients must provide signed written informed consent * Patients with clinical or histological diagnosis of HCC based on the guidelines of the Korean Liver Cancer Study Group and the National Cancer Center Korea * Patients with at least one, bi-dimensionally measurable lesion by multiphasic spiral CT scan or dynamic contrast-enhanced MRI * Patients with stage III or IVa HCC according to modified International Union Against Cancer TNM staging criteria without invasion in main portal vein, or inferior vena cava and extrahepatic metastasis and size of largest tumor 10cm at study entry * Patients with unresectable or inoperable HCC indicated for TACE as a treatment of choice according to the guidelines of the Korean Liver Cancer Study Group and the National Cancer Center Korea * Age ≥ 20 years * ECOG Performance Status of 0 or1 * Child-Pugh class A or B (Child-Pugh score 7) * Life expectancy of at least 16 weeks * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: * 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 Exclusion Criteria: * Patients with diffuse infiltrative type of HCC that are poorly defined * Presence of hepatic encephalopathy and intractable ascites * Active clinically serious infections (\> grade 2 NCI-CTC version 3.0), including spontaneous bacterial peritonitis * History of esophageal or gastric variceal bleeding * Patients who are on a liver transplant list * History of cardiac disease: congestive heart failure \> NYHA class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed), cardiac arrythmias requiring anti-arrythmic therapy or uncontrolled hypertension and diabetes mellitis * History of AIDS/HIV infection -Patients with seizure disorder requiring medication (such as steroids or anti- epileptics) * History of organ allograft * Patients with evidence or history of bleeding diathesis * Patients undergoing renal dialysis * Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1) or any cancer curatively treated \> 3 years prior to study entry.