Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-02 @ 12:27 AM
Study NCT ID:
NCT04912258
Status:
UNKNOWN
Last Update Posted:
2021-06-03
First Post:
2021-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis
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': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'liver relapse-free survival', 'timeFrame': '6 months', 'description': 'from liver surgery to liver relapse'}], 'secondaryOutcomes': [{'measure': 'relapse-free survival', 'timeFrame': '6 months'}, {'measure': 'overall survival', 'timeFrame': '12 months'}, {'measure': 'response rate', 'timeFrame': '2 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Liver Metastases']}, 'descriptionModule': {'briefSummary': 'Trans arterial chemoembolization using Irinotecan Drug-eluting Beads before liver surgery for patients with primarily unresectable colorectal liver metastasis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Histologically proven colorectal liver metastasis；\n* With liver-dominant disease；\n* Primarily evaluated as potentially resectable and conversed successfully\n* Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3 (within 1 week prior to randomization)\n* Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl (within 1 week prior to randomization);\n* Written informed consent for participation in the trial.\n\nExclusion Criteria:\n\n* Primarily evaluated as resectable\n* Failed to converse\n* Patients with known hypersensitivity reactions to any of the components of the study treatments.\n* Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding\n* Other previous malignancy within 5 years\n* Known drug abuse/ alcohol abuse\n* Legal incapacity or limited legal capacity'}, 'identificationModule': {'nctId': 'NCT04912258', 'briefTitle': 'Preoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Trans-arterial Chemoembolization With Irinotecan Drug-eluting Beads Before Liver Surgery for Patients With Primary Unresectable Colorectal Liver Metastasis: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'PIDUC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'DEB-TACE before liver surgery', 'interventionNames': ['Drug: Trans arterial chemoembolization with Irinotecan Drug-eluting Beads']}, {'type': 'NO_INTERVENTION', 'label': 'Arm B', 'description': 'direct liver surgery'}], 'interventions': [{'name': 'Trans arterial chemoembolization with Irinotecan Drug-eluting Beads', 'type': 'DRUG', 'otherNames': ['Irinotecan Drug-eluting Beads'], 'description': 'preoperative chemoembolization with Irinotecan Drug-eluting Beads', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Jianmin Xu', 'role': 'CONTACT', 'email': '13301050195@fudan.edu.cn', 'phone': '18834823867', 'phoneExt': '18834823867'}], 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jianmin Xu', 'role': 'CONTACT', 'email': 'xujmin@aiiyun.com', 'phone': '+8613501984869', 'phoneExt': '+8613501984869'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}