Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT02724267
Status:
COMPLETED
Last Update Posted:
2016-03-31
First Post:
2016-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Internal Radiation Therapy in Advanced HCC Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C576180', 'term': '131I-chimeric TNT-1-B monoclonal antibody'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, '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 Progression', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['131I-chTNT-1/B treatment'], 'conditions': ['Internal Radiation', 'Advanced Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the 131I-chTNT-1/B treatment effect and safety of individual therapy using randomized controlled study, in order to acquire the evidence of evidence-based medicine and create a new program of targeted internal radiation therapy in advanced HCC patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Via clinical diagnosis and confirm it is advanced hepatocellular carcinoma\n2. mRECIST estimation: necrosis region in HCC\n3. Negative iodine allergy test\n4. Liver function ：Child-Pugh A/B\n\nExclusion Criteria:\n\n1. reject to attend；\n2. impossible to come to our hospital for physical examination regularly.\n3. Blood clotting function hindrance; 4, Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.'}, 'identificationModule': {'nctId': 'NCT02724267', 'briefTitle': 'Targeted Internal Radiation Therapy in Advanced HCC Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Hepatobiliary Surgery Hospital'}, 'officialTitle': 'A Randomized Controlled Prospective Study of Targeted Internal Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma.', 'orgStudyIdInfo': {'id': 'ZD201208002-P1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'transcatheter arterial chemoembolization', 'description': 'Patients will be treated with TACE only.', 'interventionNames': ['Biological: 131I-chTNT-1/B']}, {'type': 'EXPERIMENTAL', 'label': 'internal radiation group', 'description': 'Patients will be treated with TACE combined with internal radiation.', 'interventionNames': ['Biological: 131I-chTNT-1/B']}], 'interventions': [{'name': '131I-chTNT-1/B', 'type': 'BIOLOGICAL', 'description': '29.6 MBq/kg,intravenous administration in 1 hour，1-3 course of treatment', 'armGroupLabels': ['internal radiation group', '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'}}}}