S-1/LV One Week on and One Week Off Regimen in Advanced Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

• Male or female, 70 years > Age > 18 years
• Patient with unresectable primary hepatocellular carcinoma
• Child-Pugh Class A or B, without ascites
• ECOG score 0
• At least one tumor nodule can be evaluated by CT or MRI
• Can take medicine orally
• Expected survival time not less than 12 weeks
• Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study During the trial and 4 week after the trial, must take contraception
• Patients must be:
• Hemoglobin > 9.0g/dl
• ANC > 1.5×109/L
• Platelet ≥ 60×109/L
• Total bilirubin < 3mg/dl
• ALT or AST < 5 X ULN
• ALP < 4 X ULN
• PT-INR < 2.3
• Patients who is taking Warfarin , should be tested every week till getting stable INR
• Serum creatinine < 1.5 X ULN
• Serum amylase and lipase < 2 X ULN

Exclusion Criteria:

• Known or suspected allergy to any agent given in association with this trial
• Local treatment within 4 weeks prior to start of study drug
• History of any heart disease
• History of HIV infection except for HBV and HCV
• Active clinically serious infections (> 2 NCI-CTC Version 3.0)
• Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry.
• Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization within 6 months prior to study entry
• Previous malignancy (except for cervical carcinoma in situ, adequate treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis and T1], early gastric cancer, or other malignancies curatively treated > 3 years prior to entry
• Extrahepatic tumor spread which affects patient's prognosis, such as bony metastasis or brain metastasis
• Hydrothorax， ascites and hydropericardium need to drain
• Serious diarrhea
• Combined with serious pulmonary diseases, such as interstitial pneumonia, pulmonary fibrosis and serious pulmonary emphysema
• Serious complication,such as intestinal obstruction,renal insufficiency, hepatic insufficiency and cerebrovascular disorders
• Pregnant or breast-feeding
• Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
• Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics.
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
• Patients unable to swallow oral medications.