Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC

Inclusion Criteria:

• Age ≥ 18 years
• Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
• patient with unresectable primary hepatocellular carcinoma
• Child-Pugh Class A or B, score ≤ 7
• ECOG score 0-2
• Expected survival time not less than 12 weeks
• At least one tumor nodule with one uni-dimension of ≥ 1 cm
• Peripheral platelet of or more than 50×10(9)/L
• Peripheral hemoglobin of or more than 85g/L
• Peripheral albumen of or more than 28g/L
• Total bilirubin ≤3.0mg/dl
• ALT and AST ≤ 5.0 x the upper limit of normal
• Serum amylase ≤ 1.5x the upper limit of normal
• Serum creatinine ≤ 1.5x upper limit of normal
• PT-INR<2.3 or PT prolong no more than 4s of normal

Exclusion Criteria:

• Congestive heart failure > NYHA class 2
• History of active coronary disease( except myocardial infarction more than 6 months ago)
• Receive anti-arrhythmia treatment(except β-receptor blocker,calcium channel blocker and digoxin)
• uncontrollable hypertension
• Active clinically serious infections (> 2 NCI-CTC Version 3.0)
• History of HIV infection
• Inclined to hemorrhage or active hemorrhage with 1 month
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
• Pregnant or breast-feeding.Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study
• Known or suspected allergy to any agent given in association with this trial
• Concomitant anti-cancer therapy (except immunotherapy and Chinese traditional treatment)
• Surgical operation within 4 weeks prior to enrolling in this portion of the study