Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT05875558
Status:
UNKNOWN
Last Update Posted:
2023-05-25
First Post:
2023-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
M-TACE Treatment 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-24', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-05-24', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': '1 month after first mTACE', 'description': 'Objective response rate according to the mRECIST'}, {'measure': 'ORR', 'timeFrame': '3 months after first mTACE', 'description': 'Objective response rate according to the mRECIST'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': '1 year', 'description': 'Overall survival'}, {'measure': 'OS', 'timeFrame': '3 years', 'description': 'Overall survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the safety and efficacy of transarterial chenmoembolization（TACE） combined with microspheres for unresectable hepatocellular carcinoma(HCC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18≤Age\\<80 on day of signing informed consent.\n2. Have histologically confirmed diagnosis or radiological diagnosis of HCC with at least one \\>3cm targeted lesion.\n3. Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease, BCLC stage A disease but refuse a surgical or ablation therapy.\n4. Have a Child-Pugh Class A/B（\\<7） liver score.\n5. Have a performance status of 0 or 1 using the ECOG.\n6. Have a predicted life expectancy of greater than 3 months.\n\nExclusion Criteria:\n\n1. The targeted lesions have received TACE or other locoregional therapy within 3 months.\n2. Tumor burden over 70% of the liver volume.\n3. Lesions can not be measured by mRECIST.\n4. Has a diagnosed additional malignancy.\n5. Patients with Hb\\<9.0g/dL, WBC\\<1.0×10\\^9/L， TB\\>3mg/dL，ALT/AST\\>5 UL, ALB\\<2.8g/dL， INR\\>2.3, Cr \\>2mg/mL or CCr\\<30mL/min.\n6. Severe heart, lung or cerebral disease.'}, 'identificationModule': {'nctId': 'NCT05875558', 'briefTitle': 'M-TACE Treatment for Unresectable Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Lipiodol Combined With Microspheres TACE for Unresectable HCC', 'orgStudyIdInfo': {'id': '2022-ZS-IR-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'M-TACE', 'interventionNames': ['Procedure: M-TACE']}], 'interventions': [{'name': 'M-TACE', 'type': 'PROCEDURE', 'description': 'Lipiodol combined with microspheres', 'armGroupLabels': ['M-TACE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Interventional Radiology, Zhongshan Hospital, Fudan University.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Zhiping Yan', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}