ActivePhase 4ACTRN12611000840987

A randomized clinical trial of adefovir to treat patients with hepatitis B-related hepatocellular carcinoma after radical tumor resection

a randomized clinical trial to study whether adefovir can improve the prognosis of HCC patients with HBV-DNA>=10000 copies/ml


Sponsor

Eastern hepatobiliary hospital

Enrollment

200 participants

Start Date

May 1, 2007

Study Type

Interventional

Conditions

Summary

The purpose of our study is to see whether anti-virus drugs can improve the prognosis of liver cancer and reduce the viral reactivity. We supposed that adefovir can reduce the tumor recurrence and viral reactivity, prolong the overall survival of patients.


Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 70 Yearss

Inclusion Criteria5

  • older than 16 years
  • HBsAg positive with HBV-DNA>=10000 copies/ml
  • histological diagnosis is HCC with chronic hepatitis in liver
  • Child A
  • tumor stage:BCLC A or B

Exclusion Criteria5

  • company with HIV/HCV
  • received anti-virus treatment in 24 weeks before randomized assignment,including interferon/thymosin/NRTI
  • metastasis or with tumor thromboli in port vein
  • can't afford to taking adefovir
  • do not sign the information consent form

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Interventions

we give adefovir 10mg oral tablet, once a day to patients in treatment group.Overall duration of antivirus treatment is according to the guideline of chronic hepatitis B. The indicatons to stop antivi

we give adefovir 10mg oral tablet, once a day to patients in treatment group.Overall duration of antivirus treatment is according to the guideline of chronic hepatitis B. The indicatons to stop antivirus treatment are as follows:1.to the patients with HBeAg(+), they should take medicine for 6-12 months after HBeAg(+) becoming HBeAg(-) and then can stop the antivirus treatment;2.to the patients with HBeAg(-), when HBV-DNA is undetectable for three times with a interval of 6 months,they can choose to stop treatment;3.to cirrhosis patients, we recommend taking antivirus treatment for whole life.


Locations(1)

Shanghai City, China

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ACTRN12611000840987