Clinical trial NCT00720668: The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma
Official title: The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Hepatocellular Carcinoma
Keywords: hepatitis B
hepatocellular carcinoma
radiofrequency ablation
reactivation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-07-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with hepatocellular carcinoma (HCC) after percutaneous radiofrequency ablation.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Rate of Exacerbation of chronic hepatitis B after RFA
timeFrame: one week, one month, one year
Secondary outcomes:
measure: survival
timeFrame: 1, 3, 5-year
measure: mortality
timeFrame: one month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
name: min-shan chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.
citation: Poon RT, Fan ST, Tsang FH, Wong J. Locoregional therapies for hepatocellular carcinoma: a critical review from the surgeon's perspective. Ann Surg. 2002 Apr;235(4):466-86. doi: 10.1097/00000658-200204000-00004.
citation: Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.