Status:
UNKNOWN
The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatitis B
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
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 ra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00720668
Start Date
June 1 2006
End Date
May 1 2010
Last Update
February 9 2009
Active Locations (1)
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1
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060