Randomized phase II study of sorafenib and hepatic arterial infusion chemotherapy with cisplatin versus sorafenib for advanced hepatocellular carcinoma

INTERVENTION: The combination chemotherapy of sorafenib with transcatheter arterial infusion of cisplatin. Sorafenib 400mg bid. 6 courses of transcatheter arterial infusion of cisplatin every 4‐6 weeks Sorafenib 400mg bid. CONDITION: advanced hepatocellular carcinoma PRIMARY OUTCOME: Overall survival SECONDARY OUTCOME: Time to progression; Advrese events; Sever advrese events; Response rate INCLUSION CRITERIA: 1) Advanced hepatocellular carcinoma with histological evidence or typical computed tomographic scans, angiographic findings and elevated serum AFP/PIVKA‐II level 2) No indication for surgical resection, liver transplantation, local ablation therapy or transarterial chemoembolization 3) No prior chemotherapy 4) Aged 20‐79 years old 5) HCCs in the Liver, with or with extrahepatic tumors which not affect patient's prognosis 6) ECOG Performance Status 0‐1 7) Adequate organ function a) Neutrophil>=1500 /mm3 b) Hb>= 8.5 g/dL c) PLT>= 60000 /mm3 d) T‐Bil<= 2.0 mg/dL e) Albumin>= 2.8 g/dL f) AST<= within 5 times of normal limit g) ALT<= within 5 times of normal limit h) Cre<= 1.2 mg/dl i) Creatinin cliarance >= 60ml/min 8) Child‐Pugh score 5‐7 points 9) Adequate indication for hepatic arterial infusion chemotherapy 10) Interval of at least 4 weeks between last treatment