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

History of Changes

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Lamivudine Entecavir Recombinant Hepatitis B vaccine Hepatitis A Vaccines

U.S. FDA Resources

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:

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

Contacts and Locations

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:

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. No abstract available.

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.

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:

Carcinoma
Hepatitis
Hepatitis A
Hepatitis B
Recurrence
Virus Diseases
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections

RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Disease Attributes
Pathologic Processes
Adenocarcinoma
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 June 18, 2013

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