Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma

February 6, 2009 updated by: Sun Yat-sen University

Efficacy of Antiviral Therapy With Lamivudine or Entecavir After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma

Most hepatocellular carcinomas are associated with hepatitis B virus, it is hypothesized that anti-viral treatment may be helpful in treating HBV-related hepatocellular carcinoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

As we know, recurrence and metastasis could happen in hepatocellular carcinoma even after radical resection.One reason is that virus hepatitis B could be one factor contributing to the carcinogenesis of hepatocellular carcinoma.To investigated whether anti-viral therapy could improve the efficacy of radical resection of hepatitis B virus (HBV)-related hepatocellular carcinoma(HCC),we planed to conduct this clinical trial.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Xiang-Ming Lao
        • Contact:
        • Principal Investigator:
          • Jin-Qing LI, Ph.D
        • Principal Investigator:
          • Xiao-Jun LIN, Ph.D
        • Principal Investigator:
          • Min-Shan CHEN, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patients who did not receive antiviral therapy prior to the resection of hepatocellular carcinoma
  2. patients who underwent radical resection of HCC, and 1 month after surgery,dynamic computed tomography showed on lesion in the liver and no signs of extrahepatic metastasis.
  3. hepatitis B surface antigen should be positive before surgery HBV-DNA level between 100000 copies/ml and 10000000copies/ml anti-HCV negative

Exclusion Criteria:

  1. previous history of antiviral therapy
  2. a baseline serum alanine aminotransferase level 2.5 times the ULN or higher
  3. positive for anti-HCV or anti-HIV
  4. Child-Pugh classification B or C after surgery
  5. preexisting evidence of hepatic decompensation, including encephalopathy,ascites,a bilirubin level more than 2 times the ULN, or a prolonged prothrombin time of more than 3 seconds
  6. signs showing recurrence or metastasis oen month after surgery
  7. underlying cardiac or renal diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: antiviral group
Drug: antiviral treatment(lamivudine or entecavir) after the Procedure/Surgery (radical resection of HBV-related HCC)
Drug: antiviral treatment (lamivudine or entecavir)
antiviral treatment (lamivudine 100mg per day or entecavir 0.5mg per day)
Procedure: radical resection of HBV-related HCC
Procedure/Surgery - radical resection of HBV-related HCC
Active Comparator: control group
Procedure/Surgery (radical resection of HBV-related HCC) without Drug of antiviral treatment - close observation without antiviral treatment
Procedure: radical resection of HBV-related HCC
Procedure/Surgery - radical resection of HBV-related HCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survivals
Time Frame: 2,3,5years
2,3,5years

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence rate
Time Frame: 2,3,5years
2,3,5years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Jin-Qing LI, Ph.D, Sun Yat-sen University
  • Study Director: Min-Shan CHEN, Ph.D, Sun Yat-sen University
  • Study Director: Xiao-Jun LIN, Ph.D, Sun Yat-sen University
  • Study Chair: Xiang-Ming LAO, Ph.D, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

October 6, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (Estimate)

October 7, 2008

Study Record Updates

Last Update Posted (Estimate)

February 9, 2009

Last Update Submitted That Met QC Criteria

February 6, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC-HCC004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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