Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-02-28 @ 11:52 AM
Study NCT ID:
NCT01936233
Status:
UNKNOWN
Last Update Posted:
2019-08-05
First Post:
2013-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D019259', 'term': 'Lamivudine'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-01', 'studyFirstSubmitDate': '2013-09-02', 'studyFirstSubmitQcDate': '2013-09-05', 'lastUpdatePostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence free survival', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '36 months'}, {'measure': 'adverse events', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'Aspirin', 'antiviral treatment', 'recurrence free survival', 'radical therapy'], 'conditions': ['Hepatocellular Carcinoma', 'Recurrence']}, 'descriptionModule': {'briefSummary': 'Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.', 'detailedDescription': 'The investigators conduct this clinical trial to evaluate the treatment outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.The primary outcome is overall survival and objective response rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features\n* Age ≥ 18 years and ≤ 75 years\n* At least one tumor nodule with one uni-dimension of ≥ 2 cm\n* Child-Pugh Class A or B\n* HBV-DNA\\>10\\^4\n* Total bilirubin ≤ 1.5 x upper limit of normal\n* ALT and AST ≤ 2.0 x the upper limit of normal\n* PT-INR\\<2.3,PTT \\< 1.5 x upper limit of normal\n* Serum creatinine ≤ 1.5x upper limit of normal\n* Peripheral white blood cell count of or more than 3×10(9)/L\n* Peripheral platelet of or more than 50×10(9)/L\n* Expected survival time not less than 3 months\n* ECOG score 0-2\n\nExclusion Criteria:\n\n* Tumor thrombi in main branch of portal vein\n* Tumor involvement more than 70% of whole liver\n* With extrahepatic metastasis\n* Prior systemic chemotherapy or chemoembolization\n* Congestive heart failure \\> NYHA class 2\n* History of HIV infection\n* Active clinically serious infections (\\> 2 NCI-CTC Version 3.0)\n* Recurrence of HCC after liver transplantation\n* Pregnant or breast-feeding\n* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study\n* Known or suspected allergy to any agent given in association with this trial\n* Patients unable to swallow oral medication\n* Inclined to thrombosis\n* Inclined to hemorrhage or active hemorrhage with 1 month"}, 'identificationModule': {'nctId': 'NCT01936233', 'briefTitle': 'Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Liver Cancer Institiute ,Fudan University', 'orgStudyIdInfo': {'id': 'LC-ASPIRIN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aspirin AND Lamivudine', 'interventionNames': ['Drug: Aspirin', 'Drug: Lamivudine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lamivudine', 'interventionNames': ['Drug: Lamivudine']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'description': 'Aspirin 0.1 QD po', 'armGroupLabels': ['Aspirin AND Lamivudine']}, {'name': 'Lamivudine', 'type': 'DRUG', 'description': 'LAminvudine 0.1 QD po', 'armGroupLabels': ['Aspirin AND Lamivudine', 'Lamivudine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zheng-Gang Ren, Ph.D', 'role': 'CONTACT', 'email': 'ren.zhenggang@zs-hospital.sh.cn', 'phone': '0086-021-64041990', 'phoneExt': '2149'}, {'name': 'Lan Zhang, Master', 'role': 'CONTACT', 'email': 'zhang.lan@zs-hospital.sh.cn', 'phone': '0086-021-64041990', 'phoneExt': '2971'}], 'facility': 'Liver Cancer Institute', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zheng-Gang Ren, Ph.D', 'role': 'CONTACT', 'email': 'ren.zhenggang@zs-hospital.sh.cn', 'phone': '0086-021-64041990', 'phoneExt': '2149'}, {'name': 'Lan Zhang, Ph.D', 'role': 'CONTACT', 'email': 'zhang.lan@zs-hospital.sh.cn', 'phone': '0086-021-64041990', 'phoneExt': '2971'}], 'overallOfficials': [{'name': 'Zhenggang Ren, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief of departement', 'investigatorFullName': 'Zheng-Gang Ren', 'investigatorAffiliation': 'Fudan University'}}}}