Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-28 @ 10:21 PM
Study NCT ID:
NCT04172194
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2019-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoarterial Treatment in Combination With Percutaneous Thermoablation for Medium-sized and Oligonodular Hepatocellular Carcinomas
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2019-11-20', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '30 minutes', 'description': 'death'}], 'secondaryOutcomes': [{'measure': 'relapse free survival', 'timeFrame': '30 minutes', 'description': 'relapse'}, {'measure': 'tolerance', 'timeFrame': '30 minutes', 'description': 'apparition of complication define by CTCAE v5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carcinoma, Hepatocellular']}, 'descriptionModule': {'briefSummary': 'Background: The association of transcatheter arterial chemotherapy infusion (TAC) with percutaneous ablation (PT) has been introduced as a method to increase the ablative zone. The aim of this study was to evaluate the efficacy of PT and TAC performed in a single session for HCCs between 30 and 50 mm or oligonodular up to 30 mm.\n\nMethods: Thirty patients with a histologically proven HCC, uninodular between 30 and 50 mm or oligonodular (n≤3) up to 30 mm, treatment-naïve and non-metastatic, received combination treatment ("PT+TAC group"). A "control" group consisted of 34 patients with uninodular HCC up to 30 mm without any poor prognostic criteria treated with PT alone ("PT group").'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with hepatocellular carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- hepatocellular carcinoma pouved by pathology,\n\nExclusion Criteria:\n\n\\- metastases'}, 'identificationModule': {'nctId': 'NCT04172194', 'briefTitle': 'Endoarterial Treatment in Combination With Percutaneous Thermoablation for Medium-sized and Oligonodular Hepatocellular Carcinomas', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Endoarterial Treatment in Combination With Percutaneous Thermoablation for Medium-sized and Oligonodular Hepatocellular Carcinomas', 'orgStudyIdInfo': {'id': '19-PT-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PT Group', 'description': 'patients with hepatocellular carcinoma treated by percutaneous thermoablation alone'}, {'label': 'PT+TAC group', 'description': 'patients with hepatocellular carcinoma treated by pecutaneous thermoablation comined in a single session with trans-arterial chemoembolization'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Nice Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}