Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-02 @ 7:09 AM
Study NCT ID:
NCT06858956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-05
First Post:
2025-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Study of Chidamide Combined With PD-(L)1 Inhibitors and Anti-Angiogenic Therapy for Advanced MSS-Type Colorectal Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C547816', 'term': 'N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000092004', 'term': 'Tyrosine Kinase Inhibitors'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D047428', 'term': 'Protein Kinase Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2025-02-28', 'studyFirstSubmitQcDate': '2025-02-28', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TTF', 'timeFrame': '24 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This is an observational , multicenter, real-world study aimed at evaluating the efficacy and safety of the combination of immune checkpoint inhibitors, chidamide and antiangiogenic agents in Microsatellite Stable advanced colorectal cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Advanced MSS-Type Colorectal Cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n\nHistologically confirmed advanced colorectal cancer with microsatellite stable (MSS)/proficient mismatch repair (pMMR) status confirmed by immunohistochemistry (IHC) or molecular testing.\n\nNo restriction on prior immunotherapy or combined anti-angiogenic agents (e.g., bevacizumab or small-molecule TKIs).\n\nECOG performance status of 0-2.\n\nAt least one post-treatment efficacy evaluation.\n\nLife expectancy ≥3 months.\n\nChidamide treatment duration \\>3 weeks\n\nExclusion Criteria:\n\n\\- 1. Malignancies in other organs or systems, except for cured basal cell/squamous cell skin cancer or cervical carcinoma.\n\n2\\. Severe comorbidities that may interfere with efficacy or safety analysis. 3. Conditions deemed unsuitable for study inclusion by the investigator.'}, 'identificationModule': {'nctId': 'NCT06858956', 'briefTitle': 'Real-World Study of Chidamide Combined With PD-(L)1 Inhibitors and Anti-Angiogenic Therapy for Advanced MSS-Type Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Real-World Study of Chidamide Combined With PD-(L)1 Inhibitors and Anti-Angiogenic Therapy for Advanced MSS-Type Colorectal Cancer', 'orgStudyIdInfo': {'id': 'CSIIT-Q99'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors', 'type': 'DRUG', 'description': 'Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aiping Zhou, PHD', 'role': 'CONTACT', 'email': 'zhouap1825@126.com', 'phone': '010-87788800'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'AIPING ZHOU', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}