Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-01 @ 6:54 PM
Study NCT ID:
NCT00768157
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2008-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'C413685', 'term': 'entecavir'}], 'ancestors': [{'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-06', 'studyFirstSubmitDate': '2008-10-06', 'studyFirstSubmitQcDate': '2008-10-06', 'lastUpdatePostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survivals', 'timeFrame': '2,3,5years'}], 'secondaryOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': '2,3,5years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'hepatitis B virus', 'surgery', 'anti-virus', 'recurrence'], 'conditions': ['Hepatocellular Carcinoma', 'Hepatitis B Virus', 'Recurrence']}, 'referencesModule': {'references': [{'pmid': '16440357', 'type': 'BACKGROUND', '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.'}, {'pmid': '17724708', 'type': 'BACKGROUND', '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.'}, {'pmid': '15336446', 'type': 'BACKGROUND', '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.'}, {'pmid': '17881079', 'type': 'BACKGROUND', '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.'}, {'pmid': '17854945', 'type': 'BACKGROUND', '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.'}, {'pmid': '12098045', 'type': 'BACKGROUND', '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.'}, {'pmid': '11141236', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients who did not receive antiviral therapy prior to the resection of hepatocellular carcinoma\n2. 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.\n3. hepatitis B surface antigen should be positive before surgery HBV-DNA level between 100000 copies/ml and 10000000copies/ml anti-HCV negative\n\nExclusion Criteria:\n\n1. previous history of antiviral therapy\n2. a baseline serum alanine aminotransferase level 2.5 times the ULN or higher\n3. positive for anti-HCV or anti-HIV\n4. Child-Pugh classification B or C after surgery\n5. 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\n6. signs showing recurrence or metastasis oen month after surgery\n7. underlying cardiac or renal diseases'}, 'identificationModule': {'nctId': 'NCT00768157', 'briefTitle': 'Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Efficacy of Antiviral Therapy With Lamivudine or Entecavir After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'SYSUCC-HCC004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'antiviral group', 'description': 'Drug: antiviral treatment(lamivudine or entecavir) after the Procedure/Surgery (radical resection of HBV-related HCC)', 'interventionNames': ['Drug: antiviral treatment (lamivudine or entecavir)', 'Procedure: radical resection of HBV-related HCC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Procedure/Surgery (radical resection of HBV-related HCC) without Drug of antiviral treatment - close observation without antiviral treatment', 'interventionNames': ['Procedure: radical resection of HBV-related HCC']}], 'interventions': [{'name': 'antiviral treatment (lamivudine or entecavir)', 'type': 'DRUG', 'description': 'antiviral treatment (lamivudine 100mg per day or entecavir 0.5mg per day)', 'armGroupLabels': ['antiviral group']}, {'name': 'radical resection of HBV-related HCC', 'type': 'PROCEDURE', 'description': 'Procedure/Surgery - radical resection of HBV-related HCC', 'armGroupLabels': ['antiviral group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang-Ming LAO, Ph.D', 'role': 'CONTACT', 'email': 'laoxming@mail.sysu.edu.cn', 'phone': '8620-87343017'}, {'name': 'Jin-Qing LI, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiao-Jun LIN, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Min-Shan CHEN, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xiang-Ming Lao', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiang-Ming LAO, Ph.D', 'role': 'CONTACT', 'email': 'laoxming@mail.sysu.edu.cn', 'phone': '8620-87343115'}, {'name': 'Xiao-Jun LIN, Ph.D', 'role': 'CONTACT', 'email': 'sumslxm@sohu.com', 'phone': '8620-87343017'}], 'overallOfficials': [{'name': 'Jin-Qing LI, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}, {'name': 'Min-Shan CHEN, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sun Yat-sen University'}, {'name': 'Xiao-Jun LIN, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sun Yat-sen University'}, {'name': 'Xiang-Ming LAO, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cancer Center of Sun Yat-sen University', 'oldOrganization': 'Cancer Center of Sun Yat-sen University'}}}}