Hepatitis B, Hepatocellular Carcinoma
Conditions
Keywords
hepatitis B, hepatocellular carcinoma, radiofrequency ablation, reactivation
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREradiofrequency ablation
radiofrequency ablation for HCC
Sponsors
Sun Yat-sen University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Rate of Exacerbation of chronic hepatitis B after RFA | one week, one month, one year |
Secondary
| Measure | Time frame |
|---|---|
| survival | 1, 3, 5-year |
| mortality | one month |
Countries
China
Contacts
Primary Contactmin-shan chen, MD
Outcome results
None listed