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
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Hepatitis B Virus
Recurrence
Drug: antiviral treatment (lamivudine or entecavir)
Procedure: radical resection of HBV-related HCC
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Antiviral Therapy With Lamivudine or Entecavir After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Overall survivals [ Time Frame: 2,3,5years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence rate [ Time Frame: 2,3,5years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: April 2007
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768157

Contacts
Contact: Xiang-Ming LAO, Ph.D 8620-87343115 laoxming@mail.sysu.edu.cn
Contact: Xiao-Jun LIN, Ph.D 8620-87343017 sumslxm@sohu.com

Locations
China, Guangdong
Xiang-Ming Lao Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Xiang-Ming LAO, Ph.D    8620-87343017    laoxming@mail.sysu.edu.cn   
Principal Investigator: Jin-Qing LI, Ph.D         
Principal Investigator: Xiao-Jun LIN, Ph.D         
Principal Investigator: Min-Shan CHEN, Ph.D         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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
  More Information

Publications:

Responsible Party: Cancer Center of Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00768157     History of Changes
Other Study ID Numbers: SYSUCC-HCC004
Study First Received: October 6, 2008
Last Updated: February 6, 2009
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
hepatocellular carcinoma
hepatitis B virus
surgery
anti-virus
recurrence

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Virus Diseases
Recurrence
Hepatitis B
Carcinoma, Hepatocellular
Carcinoma
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Disease Attributes
Pathologic Processes
Hepadnaviridae Infections
DNA Virus Infections
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Antiviral Agents
Lamivudine
Entecavir
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014