[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mismatch-repair-deficient-gastroesophageal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mismatch-repair-deficient-gastroesophageal-adenocarcinoma":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":35,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100656701","research-on-effective-strategies-after-immunotherapy-for-mismatch-repair-deficient-early-stage-gi-tumors-100656701",false,"NCT07829081","Research on Effective Strategies After Immunotherapy for Mismatch Repair-deficient Early-stage GI Tumors","RESIST","Inclusion Criteria:\n\nPart A and Part B:\n\n* Consent and Capacity:\n* Participant is 18 years of age or older.\n* Participant is legally competent and able to provide informed consent.\n* Participant has provided the appropriate written consent\n* Diagnosis: Histologically confirmed gastro-oesophageal, colon or rectum cancer, showing mismatch repair-deficiency (MMRd) by immunohistochemistry (loss of immunoreactivity for at least one of the following proteins: MLH1, PMS2, MSH2 and\u002For MSH6).\n* Clinical Stage: Non-metastatic, locally advanced disease, defined as:\n* cT2-T4, cN0-2, cM0 for gastro-oesophageal or rectum cancer\n* cT4 and\u002For cN+, cM0 for colon cancer\n* Therapy with immune checkpoint inhibitor (ICI) as primary treatment, either:\n* Combination ICI therapy (e.g., anti-PD-1 plus anti-CTLA-4 such as nivolumab + ipilimumab) or\n* Single-agent ICI therapy (e.g., pembrolizumab, atezolizumab, or other anti- PD(L)1 agents)\n\nPart B only:\n\n* Patient consents to participate in surveillance study\n* Complete or near complete response (\\*) to primary ICI treatment, as determined by local multidisciplinary team (MDT) assessment, based on restaging 8 weeks after termination of the ICI treatment:\n* Radiological imaging (CT\u002FMRI\u002FPET-CT),\n* Endoscopic findings, and\n* Clinical parameters (e.g., normalization of tumor markers, absence of symptoms \\*\\*)\n\n  * Note: in case of near complete response up to a total of 12 months of ICI is allowed following multidisciplinary team (MDT) discussion. After diagnosis of a near-complete response, tumor reassessments should be performed every 3 months up to a total treatment period of 12 months. If a complete tumor response is observed within the 12-month period, it should be recorded as the best overall response.\n\n    * Note: Assessment of complete or near complete response does not incorporate ctDNA test results\n\nExclusion Criteria:\n\n* Recurrent Disease: Known history of previously treated gastrointestinal cancer with recurrence at time of inclusion.\n* Metastatic Disease: Evidence of distant metastases (M1) at any point prior to or during ICI therapy.\n* Other Malignancies: Active second malignancy (excluding non-melanoma skiN cancer or in-situ cervical carcinoma) that may interfere with study outcomes or surveillance.\n\nPart B only:\n\n* Inadequate response to ICI: Patients with progressive disease, stable disease, or partial response deemed unsuitable for non-operative management.\n* Prior Treatment: Any prior systemic therapy, radiotherapy or surgery for the current colon cancer diagnosis before ICI treatment (except biopsy)\n* Medical or Psychiatric Conditions: Significant comorbid conditions or psychiatric illness that, in the opinion of the investigator, would impair the patient's ability to comply with protocol requirements, including surveillance.\n* Logistical Barriers: Social, geographic, or organizational factors (e.g., lack of access to regular follow-up care, inability to attend surveillance visits) that would prevent adherence to the active surveillance protocol.","ALL","18 Years",{"count":19,"type":20},234,"ESTIMATED","OBSERVATIONAL","This cohort study is divided into two parts:\n\nPart A: Registry Cohort All patients with non-metastatic, MMRd\u002FMSI-H colorectal cancers (and other gastrointestinal cancers for exploratory analysis) who have signed the general research consent will be included in a prospective registry. This includes patients who undergo primary surgical resection (+\u002F- neoadjuvant\u002Fadjuvant therapy) or following immunotherapy, regardless of response.\n\nPart A is a multicenter observational registry with both prospective and retrospective enrolment. Prospective enrolment includes eligible patients entered into the registry after activation of the study at the respective participating site. Retrospective enrolment includes eligible patients diagnosed on or after 1 January 2024 whose clinical data were generated prior to registry activation. Both prospectively and retrospectively enrolled patients contribute to the registry analyses.\n\nPart B: Active Surveillance Cohort (Surveillance Study) A subset of patients from Part A who achieve a complete or near-complete response to ICI therapy, wish to avoid surgery, and are deemed appropriate for non-operative management by a multidisciplinary tumor board are offered inclusion in a phase II surveillance study (Part B). Patients enrolled in Part B will be analysed for the primary endpoint.",[24,25,26,27,28,29,30,31,32,33,34],"Quality of Life (QOL)","Mismatch Repair Deficient Colorectal Cancer","Microsatellite Instability-High Colorectal Cancer","Stage II Colorectal Cancer","Stage III Colorectal Cancer","Mismatch Repair- Deficient Rectal Cancer","Microsatellite Instability-High Rectal Cancer","Mismatch Repair-Deficient Colon Cancer","Mismatch Repair-Deficient Gastroesophageal Adenocarcinoma","Microsatellite Instability-High Gastroesophageal Adenocarcinoma","Mismatch Repair-Deficient Gastric Cancer",[36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62],"Mismatch Repair Deficiency","Active Surveillance","Microsatellite High","Microsatellite instability-high","MMRd colorectal cancer","MSI-H colorectal cancer","MSI-H gastric cancer","Stage II colorectal cancer","Stage III colorectal cancer","Immune checkpoint inhibitor","ICI therapy","PD-1 inhibitor","PD-L1 inhibitor","Combination immunotherapy","Complete clinical response","Near-complete response","Pathological complete response","Non-operative management","Watch-and-wait","Surveillance cohort","Prospective registry","Retrospective registry","Relapse-free survival","Response-guided therapy","ctDNA monitoring","Endoscopic surveillance","Salvage surgery","RECRUITING","2026-09-14",{"date":66,"type":67},"2026-09-18","ACTUAL",{"date":69,"type":67},"2026-09-01",{"date":71,"type":20},"2033-08-31",{"name":73,"class":74},"University Hospital, Basel, Switzerland","OTHER",3]