Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-30 @ 3:29 AM
Study NCT ID:
NCT01959061
Status:
UNKNOWN
Last Update Posted:
2017-03-13
First Post:
2013-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C068874', 'term': 'raltitrexed'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D004998', 'term': 'Ethiodized Oil'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007459', 'term': 'Iodized Oil'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2013-09-18', 'studyFirstSubmitQcDate': '2013-10-07', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survivial', 'timeFrame': '8 months after last patient randomized', 'description': 'From date of randomization until date of first documented PD, date of death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Advanced colorectal cancer of liver metastatic'], 'conditions': ['Colorectal Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer', 'detailedDescription': 'evaluate the efficacy and safety of Raltitrexed and oxaliplatin and lipiodol transcatheter arthrial chemoembolization for in refractory colorectal carcinoma with liver metastases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed colorectal adenocarcinoma\n2. Disease limited to the liver Unresectable disease by surgery or other local therapies\n3. Age \\>18 years\n4. ECOG performance status 0-2,Child pugh A or B\n5. Expected survival ≥ 3 months\n6. Adequate hematological, hepatic, and renal function\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Patients with severe organ dysfunction or failure\n3. With severe cardiovascular disease, or mental\n4. Extraliver metastases'}, 'identificationModule': {'nctId': 'NCT01959061', 'acronym': 'TACE', 'briefTitle': 'Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nanjing Chia-tai Tianqing Pharmaceutical'}, 'officialTitle': 'Raltitrexed and Oxaliplatin and Lipiodol Transcatheter Arterial Chemoembolization for Advanced Colorectal Cancer', 'orgStudyIdInfo': {'id': 'NJCTTQ-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Raltitrexed and Oxaliplatin', 'description': 'Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle.', 'interventionNames': ['Drug: Raltitrexed', 'Drug: Oxaliplatin', 'Drug: lipiodol']}], 'interventions': [{'name': 'Raltitrexed', 'type': 'DRUG', 'description': '4mg, every 4 weeks,transhepatic arterial infusion', 'armGroupLabels': ['Raltitrexed and Oxaliplatin']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': '100\\~150mg, every 4 weeks, transhepatic arterial infusion', 'armGroupLabels': ['Raltitrexed and Oxaliplatin']}, {'name': 'lipiodol', 'type': 'DRUG', 'description': '5-20ml, every 4 weeks, hepatic artery embolization', 'armGroupLabels': ['Raltitrexed and Oxaliplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianhua Wang', 'role': 'CONTACT'}], 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jianhua Wang', 'role': 'CONTACT', 'email': 'wang.jianhua@zs-hospital.sh.cn', 'phone': '021-64041990'}], 'overallOfficials': [{'name': 'Jianhua Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Chia-tai Tianqing Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}