Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-14 @ 1:26 PM
Study NCT ID:
NCT01393093
Status:
UNKNOWN
Last Update Posted:
2017-06-12
First Post:
2011-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas
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': 'D016461', 'term': 'Chemoembolization, Therapeutic'}], 'ancestors': [{'id': 'D004621', 'term': 'Embolization, Therapeutic'}, {'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D060205', 'term': 'Therapeutic Occlusion'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2840}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-09', 'studyFirstSubmitDate': '2011-07-11', 'studyFirstSubmitQcDate': '2011-07-12', 'lastUpdatePostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression', 'timeFrame': '3 years', 'description': 'Time to progression'}], 'secondaryOutcomes': [{'measure': 'total survival', 'timeFrame': '3 year', 'description': 'total survival'}, {'measure': 'remission rate', 'timeFrame': '3 years', 'description': 'remiision rate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HCC', 'TACE'], 'conditions': ['Carcinoma, Hepatocellular']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.tjmuch.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating advance-stage Hepatocellular Carinoma(HCC).', 'detailedDescription': 'This is a prospective, multicentre, random, controlled clinical trial of Transcatheter Arterial Chemoembolization (TACE)with KMG Microsphere Treating Advance-stage Hepatocellular Carinomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Hepatocellular Carinomas with diagnosis of pathology or cytology or consistent with China 2001 guideline of Clinical Diagnosis Hepatocellular Carinomas\n2. clinical stage（The Barcelona Liver Clinic staging system,BCLC B and C)，or can not receive surgical intervention\n3. liver function:Child-Pugh A、B\n4. PST 0-1（Eastern Cooperative Oncology Group Performance Score ,ECOG）\n5. Lifespan≥6 months\n6. First time to receive treatment\n7. Can accept the follow up\n8. informed consent was gotten\n9. the number of lesion ≤ 5\n\nExclusion Criteria:\n\n1. pregnant or lactation woman\n2. emotional disturbance\n3. serious heart ,lung disfunction or serious diabetes mellitus\n4. serious reactiveness infections;（exp:type B or C hepatitis）\n5. liver function :Child-Pugh Score C\n6. thrombocyte\\<6×109/L\n7. diffuse HCC\n8. widespread metastasis\n9. serious atherosclerosis\n10. acquired immunodeficiency syndrome;AIDS\n11. thrombosis or thrombosis event in 6 months\n12. renal inadequacy who need hemodialysis or peritoneal dialysis\n13. with other tumors except basal cell carcinoma and carcinoma in situ of cervix\n14. serious alimentary tract hemorrhage in 4 weeks'}, 'identificationModule': {'nctId': 'NCT01393093', 'acronym': 'TACE-KMG', 'briefTitle': 'Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'Clinical Trial of Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas', 'orgStudyIdInfo': {'id': 'TMU-CIH-IR-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TACE -oil', 'description': 'embolization agent:Iodinated Oil or /and gelatin sponge Iodinated Oil （5-30ml）with Epirubicin （30-40mg/m2） or and gelatin sponge', 'interventionNames': ['Procedure: Therapeutic Chemoembolization']}, {'type': 'EXPERIMENTAL', 'label': 'TACE-KMG ( routine dose Chemo)', 'description': 'embolization agent:KMG microsphere( 150-450µm,0.2-2g) with routine dose Epirubicin （30-40mg/m2）', 'interventionNames': ['Procedure: Therapeutic Chemoembolization']}, {'type': 'EXPERIMENTAL', 'label': 'TACE-KMG( low dose Chemo )', 'description': 'embolization agent:KMG microsphere( 150-450µm,0.2-2g) with low dose Epirubicin （5-10mg/m2）', 'interventionNames': ['Procedure: Therapeutic Chemoembolization']}, {'type': 'EXPERIMENTAL', 'label': 'TACE-KMG(withou chemo)', 'description': 'embolization agent:KMG microsphere( 150-450µm,0.2-2g)', 'interventionNames': ['Procedure: Therapeutic Chemoembolization']}], 'interventions': [{'name': 'Therapeutic Chemoembolization', 'type': 'PROCEDURE', 'otherNames': ['Transcatheter Arterial Chemoembolization，TACE'], 'description': 'Transcatheter Arterial Chemoembolization', 'armGroupLabels': ['TACE -oil', 'TACE-KMG ( routine dose Chemo)', 'TACE-KMG( low dose Chemo )', 'TACE-KMG(withou chemo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhi Guo, MD', 'role': 'CONTACT', 'email': 'cjr.guozhi@vip.163.com', 'phone': '13920076145'}, {'name': 'Haipeng Yu, MD', 'role': 'CONTACT', 'email': 'jieruke@yahoo.com.cn', 'phone': '13352070835'}, {'name': 'Wenge Xing, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tianjin Medical University Cancer Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Zhi Guo, MD', 'role': 'CONTACT', 'email': 'cjr.guozhi@vip.163.com', 'phone': '13920076145'}, {'name': 'Haipeng Yu, MD', 'role': 'CONTACT', 'email': 'jieruke@yahoo.com.cn', 'phone': '13352070835'}], 'overallOfficials': [{'name': 'Zhi Guo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tianjin Medical University Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}