Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT01102335
Status:
UNKNOWN
Last Update Posted:
2010-04-13
First Post:
2010-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy
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': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], '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': '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': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077712', 'term': 'Telbivudine'}], 'ancestors': [{'id': 'D013936', 'term': 'Thymidine'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-04-12', 'studyFirstSubmitDate': '2010-04-08', 'studyFirstSubmitQcDate': '2010-04-12', 'lastUpdatePostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hepatitis B virus', 'Antiviral Agents', 'Liver Neoplasms', 'Drug Toxicity', 'Survival'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to elucidate the influence of anti-hepatitis B virus therapy on safety and survival of HCC patient after transcatheter arterial chemoembolization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hepatocellular carcinoma\n* treated with transcatheter arterial chemoembolization (TACE)\n* HBVDNA \\> 10\\^3copies/mL, including alanine aminotransferase (ALT) normal patient\n* expected survive time \\> 1 year\n* HBV marker positive (anyone of HbsAg, HbsAb, HbeAg, HbeAb and HbcAb)\n\nExclusion Criteria:\n\n* antiviral therapy history\n* alanine aminotransferase (ALT) \\>400 U/L\n* serum total bilirubin \\> 50 μmol/L\n* HBVDNA \\> 10\\^9copies/mL\n* extrahepatic metastasis or main portal vein embolus\n* apparent cardiac or pulmonary dysfunction\n* liver function: Child B or Child C\n* HCV infection'}, 'identificationModule': {'nctId': 'NCT01102335', 'acronym': 'TACEHBV', 'briefTitle': 'Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'The Observation Of Safety And Survival Of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization Combined With Anti-hepatitis B Virus Therapy', 'orgStudyIdInfo': {'id': 'LCI-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telbivudine', 'interventionNames': ['Procedure: Transcatheter arterial chemoembolization (TACE)', 'Drug: Telbivudine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TACE only', 'interventionNames': ['Procedure: Transcatheter arterial chemoembolization (TACE)']}], 'interventions': [{'name': 'Transcatheter arterial chemoembolization (TACE)', 'type': 'PROCEDURE', 'description': 'The procedure is performed under local anaesthesia. The femoral artery at groin region is punctured for arterial access. Angiography is performed for demonstration of vascular structures before embolization.The arteries supplying the tumor are selectively catheterized, this includes the hepatic arteries or other extrahepatic collateral arteries.The chemotherapeutic agent(s) is mixed with lipiodol (an oily contrast) to enhance tumour uptake. Following delivery of the lipiodol/chemotherapy mixture, small gelfoam particles may be injected to reinforce the effect of treatment.', 'armGroupLabels': ['TACE only', 'Telbivudine']}, {'name': 'Telbivudine', 'type': 'DRUG', 'otherNames': ['Sebivo'], 'description': 'anti-HBV drug', 'armGroupLabels': ['Telbivudine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jinglin xia, MD', 'role': 'CONTACT'}, {'name': 'jinglin xia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Liver cancer institute, Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'jinglin xia, MD', 'role': 'CONTACT', 'email': 'xia.jinglin@zs-hospital.sh.cn'}, {'name': 'biwei yang', 'role': 'CONTACT', 'email': 'yang.biwei@zs-hospital.sh.cn'}], 'overallOfficials': [{'name': 'jinglin xia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liver cancer institute, Zhongshan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Jing-lin Xia', 'oldOrganization': 'Liver Cancer Institute'}}}}