Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-03-05 @ 3:14 PM
Study NCT ID:
NCT02724332
Status:
COMPLETED
Last Update Posted:
2016-03-31
First Post:
2016-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Anti-Recurrence Treatment With Rapamycin on Early-stage HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-28', 'studyFirstSubmitDate': '2016-03-28', 'studyFirstSubmitQcDate': '2016-03-28', 'lastUpdatePostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Time to recurrence', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aspartate beta hydroxylase', 'transcatheter arterial chemoembolization'], 'conditions': ['Hepatocellular Carcinoma', 'Rapamycin']}, 'descriptionModule': {'briefSummary': 'To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with overexpression of ASPH after radical surgery using randomized controlled study and provide a new anti-recurrence treatment for HCC patients after operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Via clinical diagnosis and confirm it is primary liver cancer\n2. Pathological evidence of HCC\n3. Estimate tumor can gain treatment of curing operation\n4. No evidence for extrahepatic metestasis\n5. liver function ：Child-Pugh A/B\n6. BCLC stage：0/1；TNM stage：Ⅰ\n\nExclusion Criteria:\n\n1. reject to attend；\n2. impossible to come to our hospital for physical examination regularly.\n3. cancer epitome、seed focus、lymph node or distant metastasis\n4. Blood clotting function hindrance; 5, Patients with other diseases which may affect the treatment mentioned.'}, 'identificationModule': {'nctId': 'NCT02724332', 'briefTitle': 'Adjuvant Anti-Recurrence Treatment With Rapamycin on Early-stage HCC', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Hepatobiliary Surgery Hospital'}, 'officialTitle': 'A Randomized Controlled Study on the Effect of Adjuvant Anti-recurrence Treatment With Rapamycin on Early-stage HCC With Overexpression of ASPH After Radical Surgery.', 'orgStudyIdInfo': {'id': 'ZD201206003-P1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Patients will be treated with radical hepatectomy only.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'transcatheter arterial chemoembolization', 'description': 'Patients will be treated with TACE', 'interventionNames': ['Drug: Rapamycin']}], 'interventions': [{'name': 'Rapamycin', 'type': 'DRUG', 'description': '2mg,po,bid', 'armGroupLabels': ['transcatheter arterial chemoembolization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200438', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Eastern hepatobilliary surgery hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Hepatobiliary Surgery Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice president of the Eastern Hepatobiliary Surgery Hospital', 'investigatorFullName': 'ShenFeng', 'investigatorAffiliation': 'Eastern Hepatobiliary Surgery Hospital'}}}}