The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma (HBV-HCC)

patients with hepatocellular carcinoma (HCC) after percutaneous radiofrequency ablation.

Inclusion Criteria:

• Age 18 - 75 years
• HBV carrier with HCC
• After percutaneous radiofrequency ablation;
• No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
• No HCV or HIV co-infection
• No previous treatment of HCC
• No previous treatment of HBV except Lamivudine

Exclusion Criteria:

• Patient compliance is poor
• Active clinically serious infections ( > grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
• Known history of human immunodeficiency virus (HIV) infection
• Known Central Nervous System tumors including metastatic brain disease
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
• Distantly extrahepatic metastasis
• History of organ allograft
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• Excluded therapies and medications, previous and concomitant
• Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization
• Prior use of systemic investigational agents for HCC
• Autologous bone marrow transplant or stem cell rescue within four months of start of study drug