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

Sun Yat-sen University

Status: Unknown

Conditions: Hepatocellular Carcinoma; Hepatitis B

Treatments: Procedure: radiofrequency ablation

Study type: Observational

Funder types: Other

Identifiers

NCT00720668

RFA006

Details and patient eligibility

About

This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome.

Full description

It has been reported that HBV replication can be reacted after chemotherapy or immunotherapy, which will lead to exacerbation of chronic hepatitis B (ECHB). It is still unknown that if percutaneous radiofrequency ablation or liver resection for hepatocellular carcinoma (HCC) will react the replication of HBV or not. This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

1

Description:

patient with hepatocellular carcinoma after radiofrequency ablation

Treatment:

Procedure: radiofrequency ablation