Back to resultsEfficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma, Hepatitis B Virus, Recurrence
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
antiviral treatment (lamivudine or entecavir)
radical resection of HBV-related HCC
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, hepatitis B virus, surgery, anti-virus, recurrence
Eligibility Criteria
Inclusion Criteria:
- patients who did not receive antiviral therapy prior to the resection of hepatocellular carcinoma
- 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.
- hepatitis B surface antigen should be positive before surgery HBV-DNA level between 100000 copies/ml and 10000000copies/ml anti-HCV negative
Exclusion Criteria:
- previous history of antiviral therapy
- a baseline serum alanine aminotransferase level 2.5 times the ULN or higher
- positive for anti-HCV or anti-HIV
- Child-Pugh classification B or C after surgery
- 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
- signs showing recurrence or metastasis oen month after surgery
- underlying cardiac or renal diseases
Sites / Locations
- Xiang-Ming LaoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
antiviral group
control group
Arm Description
Drug: antiviral treatment(lamivudine or entecavir) after the Procedure/Surgery (radical resection of HBV-related HCC)
Procedure/Surgery (radical resection of HBV-related HCC) without Drug of antiviral treatment - close observation without antiviral treatment
Outcomes
Primary Outcome Measures
Overall survivals
Secondary Outcome Measures
Recurrence rate
Full Information
NCT ID
NCT00768157
First Posted
October 6, 2008
Last Updated
February 6, 2009
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT00768157
Brief Title
Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma
Official Title
Efficacy of Antiviral Therapy With Lamivudine or Entecavir After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Hepatitis B Virus, Recurrence
Keywords
hepatocellular carcinoma, hepatitis B virus, surgery, anti-virus, recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
antiviral group
Arm Type
Experimental
Arm Description
Drug: antiviral treatment(lamivudine or entecavir) after the Procedure/Surgery (radical resection of HBV-related HCC)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Procedure/Surgery (radical resection of HBV-related HCC) without Drug of antiviral treatment - close observation without antiviral treatment
Intervention Type
Drug
Intervention Name(s)
antiviral treatment (lamivudine or entecavir)
Intervention Description
antiviral treatment (lamivudine 100mg per day or entecavir 0.5mg per day)
Intervention Type
Procedure
Intervention Name(s)
radical resection of HBV-related HCC
Intervention Description
Procedure/Surgery - radical resection of HBV-related HCC
Primary Outcome Measure Information:
Title
Overall survivals
Time Frame
2,3,5years
Secondary Outcome Measure Information:
Title
Recurrence rate
Time Frame
2,3,5years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients who did not receive antiviral therapy prior to the resection of hepatocellular carcinoma
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.
hepatitis B surface antigen should be positive before surgery HBV-DNA level between 100000 copies/ml and 10000000copies/ml anti-HCV negative
Exclusion Criteria:
previous history of antiviral therapy
a baseline serum alanine aminotransferase level 2.5 times the ULN or higher
positive for anti-HCV or anti-HIV
Child-Pugh classification B or C after surgery
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
signs showing recurrence or metastasis oen month after surgery
underlying cardiac or renal diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang-Ming LAO, Ph.D
Phone
8620-87343115
Email
laoxming@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Jun LIN, Ph.D
Phone
8620-87343017
Email
sumslxm@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Qing LI, Ph.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Min-Shan CHEN, Ph.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xiao-Jun LIN, Ph.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xiang-Ming LAO, Ph.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Xiang-Ming Lao
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang-Ming LAO, Ph.D
Phone
8620-87343017
Email
laoxming@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Jin-Qing LI, Ph.D
First Name & Middle Initial & Last Name & Degree
Xiao-Jun LIN, Ph.D
First Name & Middle Initial & Last Name & Degree
Min-Shan CHEN, Ph.D
12. IPD Sharing Statement
Citations:
PubMed Identifier
16440357
Citation
Jang JW, Choi JY, Bae SH, Yoon SK, Chang UI, Kim CW, Cho SH, Han JY, Lee YS. A randomized controlled study of preemptive lamivudine in patients receiving transarterial chemo-lipiodolization. Hepatology. 2006 Feb;43(2):233-40. doi: 10.1002/hep.21024.
Results Reference
background
PubMed Identifier
17724708
Citation
Jang JW, Choi JY, Bae SH, Yoon SK, Woo HY, Chang UI, Kim CW, Nam SW, Cho SH, Yang JM, Lee CD. The impact of hepatitis B viral load on recurrence after complete necrosis in patients with hepatocellular carcinoma who receive transarterial chemolipiodolization: implications for viral suppression to reduce the risk of cancer recurrence. Cancer. 2007 Oct 15;110(8):1760-7. doi: 10.1002/cncr.22984.
Results Reference
background
PubMed Identifier
15336446
Citation
Jang JW, Choi JY, Bae SH, Kim CW, Yoon SK, Cho SH, Yang JM, Ahn BM, Lee CD, Lee YS, Chung KW, Sun HS. Transarterial chemo-lipiodolization can reactivate hepatitis B virus replication in patients with hepatocellular carcinoma. J Hepatol. 2004 Sep;41(3):427-35. doi: 10.1016/j.jhep.2004.05.014.
Results Reference
background
PubMed Identifier
17881079
Citation
Poon RT. Significance of viral status on prognosis after resection of hepatitis B virus related hepatocellular carcinoma. J Hepatol. 2007 Nov;47(5):630-1. doi: 10.1016/j.jhep.2007.08.007. Epub 2007 Sep 5. No abstract available.
Results Reference
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PubMed Identifier
17854945
Citation
Sun HC, Zhang W, Qin LX, Zhang BH, Ye QH, Wang L, Ren N, Zhuang PY, Zhu XD, Fan J, Tang ZY. Positive serum hepatitis B e antigen is associated with higher risk of early recurrence and poorer survival in patients after curative resection of hepatitis B-related hepatocellular carcinoma. J Hepatol. 2007 Nov;47(5):684-90. doi: 10.1016/j.jhep.2007.06.019. Epub 2007 Aug 13.
Results Reference
background
PubMed Identifier
12098045
Citation
Kubo S, Hirohashi K, Yamazaki O, Matsuyama M, Tanaka H, Horii K, Shuto T, Yamamoto T, Kawai S, Wakasa K, Nishiguchi S, Kinoshita H. Effect of the presence of hepatitis B e antigen on prognosis after liver resection for hepatocellular carcinoma in patients with chronic hepatitis B. World J Surg. 2002 May;26(5):555-60. doi: 10.1007/s00268-001-0267-1. Epub 2002 Feb 19.
Results Reference
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PubMed Identifier
11141236
Citation
Kubo S, Nishiguchi S, Hamba H, Hirohashi K, Tanaka H, Shuto T, Kinoshita H, Kuroki T. Reactivation of viral replication after liver resection in patients infected with hepatitis B virus. Ann Surg. 2001 Jan;233(1):139-45. doi: 10.1097/00000658-200101000-00020.
Results Reference
background
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Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma
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