Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
Study NCT ID:
NCT03783559
Status:
UNKNOWN
Last Update Posted:
2019-06-12
First Post:
2018-12-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TACE(Transcatheter Arterial Chemoembolization ) Associated With Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Patients With Unresectable CRLM(Colorectal Liver Metastases)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-11', 'studyFirstSubmitDate': '2018-12-15', 'studyFirstSubmitQcDate': '2018-12-20', 'lastUpdatePostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '6 months'}, {'measure': 'conversion resection rates', 'timeFrame': '2-4months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer liver metastasis', 'Transarterial chemoembolization', 'conversion resection rates', 'chemotherapy'], 'conditions': ['Colorectal Adenocarcinoma Metastatic to the Liver']}, 'referencesModule': {'references': [{'pmid': '33611431', 'type': 'DERIVED', 'citation': 'Liu Y, Chang W, Zhou B, Wei Y, Tang W, Liang F, Chen Y, Yan Z, Lv M, Ren L, Xu J. Conventional transarterial chemoembolization combined with systemic therapy versus systemic therapy alone as second-line treatment for unresectable colorectal liver metastases: randomized clinical trial. Br J Surg. 2021 Apr 30;108(4):373-379. doi: 10.1093/bjs/znaa155.'}, {'pmid': '32163181', 'type': 'DERIVED', 'citation': 'Swierz MJ, Storman D, Riemsma RP, Wolff R, Mitus JW, Pedziwiatr M, Kleijnen J, Bala MM. Transarterial (chemo)embolisation versus no intervention or placebo for liver metastases. Cochrane Database Syst Rev. 2020 Mar 12;3(3):CD009498. doi: 10.1002/14651858.CD009498.pub4.'}]}, 'descriptionModule': {'briefSummary': 'To date no randomized controlled trials have been completed that demonstrated whether TACE(Transarterial chemoembolization) is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversion resection rates and survival compared with chemotherapy (target therapy) alone for patients who failed with first-line chemotherapy.The primary objective of this trial is to determine conversion resection rates and survival for patients with colorectal cancer liver metastasis are treated with TACE plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy in the 2nd, and 3rd line.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologically confirmed CRLM\n* disease limited to the liver Unresectable disease by surgery or other local therapies\n* Age \\> 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2,child pugh A or B\n* Expected survival ≥ 3 months\n* Adequate hematological, hepatic and renal function\n* PD(progressive disease) after first line chemotherapy\n\nExclusion Criteria:\n\n* pregnant or lactating women\n* patients with severe organ dysfunction or failure\n* with severe cardiovascular or mental disease'}, 'identificationModule': {'nctId': 'NCT03783559', 'briefTitle': 'TACE(Transcatheter Arterial Chemoembolization ) Associated With Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Patients With Unresectable CRLM(Colorectal Liver Metastases)', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'TACE Associated With Systemic Chemotherapy Versus Systemic Chemotherapy in Patients Who Failed With First Line Chemotherapy', 'orgStudyIdInfo': {'id': 'TACECRLM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'TACE plus chemotherapy ± target therapy', 'interventionNames': ['Drug: TACE', 'Drug: chemotherapy±target therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'description': 'chemotherapy ± target therapy', 'interventionNames': ['Drug: chemotherapy±target therapy']}], 'interventions': [{'name': 'TACE', 'type': 'DRUG', 'description': 'TACE', 'armGroupLabels': ['Arm A']}, {'name': 'chemotherapy±target therapy', 'type': 'DRUG', 'description': 'chemotherapy±target therapy', 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Department of General Surgery, Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jianmin Xu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Xu jianmin', 'investigatorAffiliation': 'Fudan University'}}}}