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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00768157
• Other study ID #: SYSUCC-HCC004
• Status: Recruiting
• Phase: Phase 4
• First received: October 6, 2008
• Last updated: February 6, 2009
• Start date: April 2007
• Est. completion date: August 2010

Study information

• Verified date: February 2009
• Source: Sun Yat-sen University
• Contact: Xiang-Ming LAO, Ph.D
• Phone: 8620-87343115
• Email: laoxming[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Virus
• Hepatocellular Carcinoma
• 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

Locations

Country	Name	City	State
China	Xiang-Ming Lao	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (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. — View 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. — View 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. — View 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. Epub 2002 Feb 19. — View 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. — View 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. Epub 2007 Sep 5. — View 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. Epub 2007 Aug 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survivals		2,3,5years	Yes
Secondary	Recurrence rate		2,3,5years	Yes