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The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma

18 Years
75 Years
Open (Enrolling)
Hepatitis B, Hepatocellular Carcinoma

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Trial Information

The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma

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.

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The Rate of Exacerbation of chronic hepatitis B after RFA

Outcome Time Frame:

one week, one month, one year

Safety Issue:


Principal Investigator

min-shan chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University


China: Ministry of Health

Study ID:




Start Date:

June 2006

Completion Date:

May 2010

Related Keywords:

  • Hepatitis B
  • Hepatocellular Carcinoma
  • hepatitis B
  • hepatocellular carcinoma
  • radiofrequency ablation
  • reactivation
  • Carcinoma
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Hepatitis, Chronic
  • Hepatitis B, Chronic
  • Carcinoma, Hepatocellular