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

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ClinicalTrials.gov Identifier: NCT00720668
Recruitment Status : Unknown
Verified February 2009 by Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : July 23, 2008
Last Update Posted : February 9, 2009
Sponsor:
Information provided by:
Sun Yat-sen University

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.

Condition or disease Intervention/treatment
Hepatitis B Hepatocellular Carcinoma Procedure: radiofrequency ablation

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.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma
Study Start Date : June 2006
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
1
patient with hepatocellular carcinoma after radiofrequency ablation
Procedure: radiofrequency ablation
radiofrequency ablation for HCC
Other Name: RFA



Primary Outcome Measures :
  1. The Rate of Exacerbation of chronic hepatitis B after RFA [ Time Frame: one week, one month, one year ]

Secondary Outcome Measures :
  1. survival [ Time Frame: 1, 3, 5-year ]
  2. mortality [ Time Frame: one month ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with hepatocellular carcinoma (HCC) after percutaneous radiofrequency ablation.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720668


Contacts
Contact: min-shan chen, MD 86-20-87343117 ext 86-20-87343117 Chminsh@mail.sysu.edu.cn

Locations
China, Guangdong
Cancer Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Min-Shan Chen, MD    86-20-87343117 ext 86-20-87343117    Chminsh@mail.sysu.edu.cn   
Principal Investigator: Min-Shan Chen, MD         
Sub-Investigator: Yao-Jun Zhang, Doctor         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: min-shan chen, MD Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

Publications of Results:
Responsible Party: minshan chen, cancer canter, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00720668     History of Changes
Other Study ID Numbers: RFA006
First Posted: July 23, 2008    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: February 2009

Keywords provided by Sun Yat-sen University:
hepatitis B
hepatocellular carcinoma
radiofrequency ablation
reactivation

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Hepatitis A
Carcinoma, Hepatocellular
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepadnaviridae Infections
DNA Virus Infections