Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-01-04 @ 3:36 AM
Study NCT ID:
NCT03125161
Status:
UNKNOWN
Last Update Posted:
2017-04-24
First Post:
2017-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing HAI Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2017-04-19', 'studyFirstSubmitQcDate': '2017-04-21', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'conversional resection rates', 'timeFrame': '2-4 months'}], 'secondaryOutcomes': [{'measure': 'overall response rates', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'liver metastasis', 'hepatic arterial infusion', 'chemotherapy', 'target therapy', 'conversional resection rates'], 'conditions': ['Colorectal Adenocarcinoma Metastatic to the Liver']}, 'descriptionModule': {'briefSummary': 'To date no prospective trials have been completed that demonstrated whether HAI is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversional resection rates and survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine conversional resection rates and survival for patients with colorectal cancer liver metastasis are treated with HAI plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients must meet the following criteria:\n* Patients must have histologically confirmed incurable CRLM and no clinical or radiographic evidence of extrahepatic disease\n* Patients is medically eligible to receive HAI, as determined by the MDT (multidisciplinary team)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Age \\> 18 years\n* Subject life expectancy \\> 3 months\n* Platelets \\> 100×103/mm3\n* Total bilirubin \\<1.5mg/dl\n* Creatinine level \\< 2.0 mg/dl\n* All patients must sign an informed consent form\n\nExclusion Criteria:\n\n* The CRLM is amenable to curative surgical therapy\n* Prior radiation, TACE or HAI to the liver\n* Uncorrectable coagulopathy\n* Subject is pregnant, nursing, or wishes to become pregnant during the study Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival\n* Current or planned treatment with any experimental chemotherapy or target drugs'}, 'identificationModule': {'nctId': 'NCT03125161', 'briefTitle': 'Study Comparing HAI Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Prospective, Randomized, One-center Study Comparing Hepatic Arterial Infusion Plus Chemotherapy ± Target Therapy and Chemotherapy ± Target Therapy Alone in Patients With Unresectable Colorectal Cancer Liver Metastases', 'orgStudyIdInfo': {'id': 'HAICRLM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'HAI plus chemotherapy ± target therapy', 'interventionNames': ['Drug: HAI', 'Drug: chemotherapy ± target therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'description': 'chemotherapy ± target therapy', 'interventionNames': ['Drug: chemotherapy ± target therapy']}], 'interventions': [{'name': 'HAI', 'type': 'DRUG', 'description': 'HAI', 'armGroupLabels': ['Arm A']}, {'name': 'chemotherapy ± target therapy', 'type': 'DRUG', 'description': 'chemotherapy ± target therapy', 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianmin Xu, PhD', 'role': 'CONTACT', 'email': 'xujmin@aiiyun.com', 'phone': '+86-13501984869'}], 'facility': 'Zhongshan hosptial, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jianmin Xu, PhD', 'role': 'CONTACT', 'email': 'xujmin@aiiyun.com', 'phone': '+86-13501984869'}], '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'}}}}