Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-11 @ 1:33 AM
Study NCT ID:
NCT02724358
Status:
COMPLETED
Last Update Posted:
2016-03-31
First Post:
2016-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rg3 in Combination With TACE in Hepatocellular Carcinoma Patients With High Expression of Notch1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D000082882', 'term': 'Bicuspid Aortic Valve Disease'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'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': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, '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': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '3 years'}, {'measure': 'Time to progression', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Carcinoma', 'Hepatocellular', 'Notch1'], 'conditions': ['Hepatocellular Carcinoma', 'TACE', 'Notch1', 'Rg3']}, 'descriptionModule': {'briefSummary': 'In order to provide a new option for clinical anti-angiogenesis therapy in hepatoma, a randomized controlled study is planed to confirm the effect of Rg3 in combination with TACE on angiogenesis and tumor treatment in advanced hepatocellular carcinoma patients with high expression of Notch1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathologically confirmed hepatocellular carcinoma.\n2. High expression of Notch1 in tumor tissues.\n\nExclusion Criteria:\n\nno pathological evidence of HCC'}, 'identificationModule': {'nctId': 'NCT02724358', 'briefTitle': 'Rg3 in Combination With TACE in Hepatocellular Carcinoma Patients With High Expression of Notch1', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Hepatobiliary Surgery Hospital'}, 'orgStudyIdInfo': {'id': '2012ZX10002016008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TACE', 'description': 'iodized oil (5ml) + Pirarubicin (20mg)', 'interventionNames': ['Procedure: TACE']}, {'type': 'EXPERIMENTAL', 'label': 'Rg3', 'description': '20mg, BID, maintained though Month 12', 'interventionNames': ['Drug: Rg3']}, {'type': 'EXPERIMENTAL', 'label': 'TACE + Rg3', 'description': 'the combination of the treatments for the above two groups. Rg3 will be stopped on the day performing TACE.', 'interventionNames': ['Other: TACE + Rg3']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'standard liver protective therapy', 'interventionNames': ['Procedure: protective therapy']}], 'interventions': [{'name': 'TACE', 'type': 'PROCEDURE', 'otherNames': ['Transcatheter Arterial Chemoembolization'], 'description': 'iodized oil (5ml) + Pirarubicin (20mg)', 'armGroupLabels': ['TACE']}, {'name': 'Rg3', 'type': 'DRUG', 'description': '20mg, BID, maintained though Month 12.', 'armGroupLabels': ['Rg3']}, {'name': 'TACE + Rg3', 'type': 'OTHER', 'armGroupLabels': ['TACE + Rg3']}, {'name': 'protective therapy', 'type': 'PROCEDURE', 'description': 'standard liver protective therapy', 'armGroupLabels': ['Control']}]}, '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'}}}}