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

• ClinicalTrials.gov Identifier: NCT00768157
• Recruitment Status: Unknown
• First Posted: October 7, 2008
• Last Update Posted: February 9, 2009
• Sponsor: Sun Yat-sen University
• Information provided by: Sun Yat-sen University

Tracking Information

• First Submitted Date: October 6, 2008
• First Posted Date: October 7, 2008
• Last Update Posted Date: February 9, 2009
• Study Start Date: April 2007
• Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 6, 2008): Overall survivals [ Time Frame: 2,3,5years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 6, 2008): Recurrence rate [ Time Frame: 2,3,5years ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hepatocellular Carcinoma
• Hepatitis B Virus
• Recurrence

Intervention

• 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

Study Arms

• 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

Publications *

• 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.
• 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.
• 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.
• 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. Epub 2007 Sep 5.
• 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. Epub 2007 Aug 13.
• 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. Epub 2002 Feb 19.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 6, 2008): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2010
• Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00768157
• Other Study ID Numbers: SYSUCC-HCC004
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Cancer Center of Sun Yat-sen University
• Study Sponsor: Sun Yat-sen University
• Collaborators: Not Provided

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

• PRS Account: Sun Yat-sen University
• Verification Date: February 2009