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Trial record 1 of 1 for:    NCT00768157
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Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00768157
First received: October 6, 2008
Last updated: February 6, 2009
Last verified: February 2009

October 6, 2008
February 6, 2009
April 2007
August 2009   (final data collection date for primary outcome measure)
Overall survivals [ Time Frame: 2,3,5years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00768157 on ClinicalTrials.gov Archive Site
Recurrence rate [ Time Frame: 2,3,5years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatocellular Carcinoma
  • Hepatitis B Virus
  • Recurrence
  • 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
  • Experimental: antiviral group
    Drug: antiviral treatment(lamivudine or entecavir) after the Procedure/Surgery (radical resection of HBV-related HCC)
    Interventions:
    • Drug: antiviral treatment (lamivudine or entecavir)
    • Procedure: 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
    Intervention: Procedure: radical resection of HBV-related HCC

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
August 2010
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Xiang-Ming LAO, Ph.D 8620-87343115 laoxming@mail.sysu.edu.cn
Contact: Xiao-Jun LIN, Ph.D 8620-87343017 sumslxm@sohu.com
China
 
NCT00768157
SYSUCC-HCC004
Yes
Cancer Center of Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Jin-Qing LI, Ph.D Cancer Center of Sun Yat-sen University
Study Director: Min-Shan CHEN, Ph.D Cancer Center of Sun Yat-sen University
Study Director: Xiao-Jun LIN, Ph.D Cancer Center of Sun Yat-sen University
Study Chair: Xiang-Ming LAO, Ph.D Cancer Center of Sun Yat-sen University
Sun Yat-sen University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP