Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-05 @ 6:24 PM
Study NCT ID:
NCT01677468
Status:
UNKNOWN
Last Update Posted:
2012-09-03
First Post:
2012-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survival According to the Feeding Artery Obliteration by Chemoembolization for Unresectable Hepatocellular Carcinoma
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': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D005781', 'term': 'Gelatin Sponge, Absorbable'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D015503', 'term': 'Surgical Sponges'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-29', 'studyFirstSubmitDate': '2012-08-09', 'studyFirstSubmitQcDate': '2012-08-29', 'lastUpdatePostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate of the subjects', 'timeFrame': '6 months after TACE', 'description': 'Survival rate of the subjects 6 months after TACE'}, {'measure': 'Survival rate of the subjects', 'timeFrame': '12 months after TACE', 'description': 'Survival rate of the subjects, 12 months after TACE'}, {'measure': 'Survival rate of the subjects', 'timeFrame': '18 months after TACE', 'description': 'Survival rate of the subjects, 18 months after TACE'}, {'measure': 'Survival rate of the subjects', 'timeFrame': '24 months after TACE', 'description': 'Survival rate of the subjects, 24 months after TACE'}], 'secondaryOutcomes': [{'measure': 'Disease free survival of the subjects', 'timeFrame': '6, 12, 18, and 24 months after TACE', 'description': 'Disease free survival of the subjects, 24 months after TACE'}, {'measure': 'Complication rate of TACE', 'timeFrame': '6, 12, 18, and 24 months after TACE', 'description': 'The incidence of infection, hemorrhage, 24 months after TACE'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'Transarterial chemoembolization'], 'conditions': ['Hepatocellular Carcinoma', 'Transarterial Chemoembolization']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.', 'detailedDescription': 'Subjective angiographic chemoembolization endpoints (SACE) levels were developed to standardize the embolic endpoints of transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). It determined the antegrade arterial flow and residual tumor blush as follows: I, normal-normal; II, reduced-reduced; III, reduced-none; IV, none-none. SACE level II and III indicates intermediate-levels of embolization, whereas IV indicates overembolization. The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18\n* ECOG performance status 0-2\n* Hepatocellular carcinoma diagnosed histologically or clinically\n* Tumor numbers of 5 or less\n* No history of treatment for hepatocellular carcinoma\n* Patients with informed consent\n\nExclusion Criteria:\n\n* Extrahepatic metastasis\n* Rupture of hepatocellular carcinoma\n* Infiltrative hepatocellular carcinoma\n* Malignancy other than hepatocellular carcinoma'}, 'identificationModule': {'nctId': 'NCT01677468', 'briefTitle': 'Survival According to the Feeding Artery Obliteration by Chemoembolization for Unresectable Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Medical Center'}, 'officialTitle': 'Phase Study About Feeding Artery Obliteration by Chemoembolization on Survival of Patients With Unresectable Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': '2011-12-122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermediate embolization', 'description': 'TACE with substatsis using gelfoam', 'interventionNames': ['Procedure: Intermediate embolization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Complete embolization', 'description': 'TACE with complete embolization using gelfoam', 'interventionNames': ['Procedure: Complete embolization']}], 'interventions': [{'name': 'Intermediate embolization', 'type': 'PROCEDURE', 'otherNames': ['Adriamycin', 'Cysplatin', 'Gelfoam'], 'description': 'TACE with substasis using gelfoam', 'armGroupLabels': ['Intermediate embolization']}, {'name': 'Complete embolization', 'type': 'PROCEDURE', 'otherNames': ['Adriamycin', 'Cysplatin', 'Gelfoam'], 'description': 'TACE with complete embolization using gelfoam', 'armGroupLabels': ['Complete embolization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '431070', 'city': 'Anyang', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Choong Kee Park, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'ckp@hallym.or.kr', 'phone': '82-31-380-3708'}], 'facility': 'Hallym Sacred Heart Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'zip': '200060', 'city': 'Chuncheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dong Joon Kim, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'djkim@hallym.ac.kr', 'phone': '82-33-741-1226'}], 'facility': 'Chuncheon Sacred Heart Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '150950', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Hoon Park, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'dr.sanghoon.park@gmail.com', 'phone': '82-2-829-5493'}, {'name': 'Sang Hoon Park, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kangnam Sacred Heart Hostpita', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sang Hoon Park, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'dr.sanghoon.park@gmail.com', 'phone': '82-2-829-5493'}, {'name': 'Su Rin Shin, M.D.', 'role': 'CONTACT', 'email': 'dr.goforit@gmail.com', 'phone': '82-2-829-5490'}], 'overallOfficials': [{'name': 'Sang Hoon Park, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hallym University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}