Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-26 @ 5:36 AM
Study NCT ID:
NCT06980350
Status:
COMPLETED
Last Update Posted:
2025-07-29
First Post:
2025-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proposal of a Novel Model for Identifying Complete Response in dMMR Colon Cancer Following Neoadjuvant Immunotherapy
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': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-05-12', 'studyFirstSubmitQcDate': '2025-05-12', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response (CR)', 'timeFrame': '1 year', 'description': 'Complete response: Pathological complete response and clinical complete response'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'A novel evaluation model for identifying complete response following neoadjuvant immune checkpoint inhibitor therapy therapy in patients with dMMR colon cancer was developed to validated its efficacy in two independent cohorts, and to assessed its feasibility for W\\&W strategy.', 'detailedDescription': 'Immunotherapy shows promise as a curative treatment for patients with non-metastatic dMMR CRC, and offers an option of watch-and-wait (W\\&W) strategy for those achieving clinical complete response (cCR). A recent study has tested this hypothesis and demonstrated that 100% of patients (n=42) with localized dMMR rectal cancer achieved cCR after 6 months of neoICI treatment. These patients were managed with a W\\&W strategy, and none experienced tumor recurrence over a median follow-up of 26.3 (range 12.4-50.5) months. This result was echoed by our previous studies, in which patients with dMMR rectal cancer who achieved cCR following neoICI demonstrated promising long-term outcomes.\n\nOrgan preservation seems promising not only in patients with dMMR rectal cancer, but also in those with dMMR colon cancer who achieve cCR. In the NEOCAP trail, 20 patients with colon cancer were managed with a W\\&W strategy, with no tumour regrowth observed over a median follow-up of 11.2 (IQR 5.1-17.7) months. However, the application of organ preservation remains a significant challenge in dMMR colon cancers. This is largely attributed to the fact that tumor responses to neoICI are more prone to be underestimated by radiological assessment. Specifically, patients with pCR were often evaluated as having residual diseases on CT scans. In the PICC trail, 80% (24/30) of patients with partial response (PR) were found to achieve pCR after tumor resection. Similarly, in the NICHE-2 study, only 2 out of 75 patients with pCR had a radiological complete response (CR).5 Hence, a more reliable evaluation model to identify pCR after neoICI in dMMR colon cancer is urgently needed.\n\nIn the present study, a novel evaluation model for identifying complete response following neoadjuvant immune checkpoint inhibitor therapy therapy in patients with dMMR colon cancer was developed to validated its efficacy in two independent cohorts, and to assessed its feasibility for W\\&W strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with dMMR colon cancer receiving neoICI therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pathologically confirmed colon adenocarcinoma;\n2. immunohistochemistry testing as dMMR tumors;\n3. received at least two doses of anti-PD-1 immunotherapy in a neoadjuvant setting.\n4. received radical surgery.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06980350', 'briefTitle': 'Proposal of a Novel Model for Identifying Complete Response in dMMR Colon Cancer Following Neoadjuvant Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Proposal of a Novel Model for Identifying Complete Response in dMMR Colon Cancer Following Neoadjuvant Immunotherapy', 'orgStudyIdInfo': {'id': 'G2023-176-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PD-1 Inhibitors', 'type': 'DRUG', 'description': 'Patients received at least two doses of anti-PD-1 immunotherapy in a neoadjuvant setting.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Peirong Ding, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Department of Colorectal Surgery', 'investigatorFullName': 'Pei-Rong Ding', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}