[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microsatellite-instability-high-msi-h\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microsatellite-instability-high-msi-h":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100657691","phase-2-ctdna-guided-immunotherapy-for-dmmrmsi-h-colon-cancer-100657691",false,"NCT07841236","ctDNA-Guided Immunotherapy for dMMR\u002FMSI-H Colon Cancer","A Single-Arm Phase II Study of Circulating Tumor DNA-Guided Neoadjuvant Immunotherapy for dMMR\u002FMSI-H Colon Cancer","Inclusion Criteria:\n\n* Written informed consent obtained before any study-related procedures.\n* Age 18 to 75 years, inclusive.\n* Histologically confirmed colon adenocarcinoma, mucinous adenocarcinoma, or signet-ring cell carcinoma, with the tumor located at least 15 cm from the anal verge.\n* dMMR\u002FMSI-H status confirmed by immunohistochemistry, polymerase chain reaction, or next-generation sequencing.\n* Eastern Cooperative Oncology Group performance status of 0 or 1 and an expected survival of at least 3 months.\n* Adequate hematologic, hepatic, renal, coagulation, thyroid, and cardiac function, as defined in the protocol.\n* Negative pregnancy test for women of childbearing potential; agreement to use highly effective contraception, when applicable.\n\nExclusion Criteria:\n\n* Prior treatment with a PD-1 inhibitor, CTLA-4 inhibitor, or other immunotherapy.\n* Symptomatic or high-risk bowel obstruction, bleeding, perforation, pneumonitis, or other conditions that may compromise safe study participation.\n* Another malignancy diagnosed within 5 years before the first study treatment, except for specified definitively treated low-risk malignancies.\n* Current participation in another interventional clinical study, or receipt of another investigational drug or investigational device within 4 weeks before the first study treatment.\n* Active autoimmune disease requiring systemic treatment within 2 years before the first study treatment, or recent systemic corticosteroid or other immunosuppressive therapy.\n* Uncontrolled pleural effusion or ascites, prior allogeneic organ transplantation (except corneal transplantation), or allogeneic hematopoietic stem cell transplantation.\n* Known hypersensitivity to any study drug component.\n* Toxicities or complications from prior treatment not recovered to Grade 1 or baseline, except for specified conditions.\n* HIV infection, untreated active hepatitis B infection, or active hepatitis C infection.\n* Receipt of a live vaccine within 30 days before the first study treatment.\n* Pregnancy or breastfeeding.\n* Any serious or uncontrolled systemic disease, active infection, clinically significant laboratory abnormality, or other condition that may interfere with study participation or place the participant at unacceptable risk, as judged by the investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},23,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This prospective, multicenter, single-arm phase II interventional study evaluates whether longitudinal circulating tumor DNA (ctDNA) monitoring can guide neoadjuvant immunotherapy and surgical decision-making in dMMR\u002FMSI-H colon cancer. Participants with ctDNA clearance proceed to curative surgery, whereas those with persistent ctDNA positivity escalate to combined PD-1 and CTLA-4 inhibitor therapy.",[27,28,29],"Colon Cancer","Deficient Mismatch Repair","Microsatellite Instability-High (MSI-H)",[31,32,33,34,35],"Circulating Tumor DNA","dMMR\u002FMSI-H Colon Cancer","Neoadjuvant Immunotherapy","Pathological Complete Response","Minimal Residual Disease","RECRUITING","2026-09-24",{"date":39,"type":40},"2026-09-25","ACTUAL",{"date":42,"type":21},"2026-09-14",{"date":44,"type":21},"2030-12-31",{"name":46,"class":47},"Fudan University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":48},"100356848","phase-2-neoadjuvant-toripalimab-with-or-without-celecoxib-in-dmmrmsi-h-colorectal-cancer-100356848","NCT03926338","Neoadjuvant Toripalimab With or Without Celecoxib in dMMR\u002FMSI-H Colorectal Cancer","Neoadjuvant PD-1 Blockade by Toripalimab With or Without Celecoxib in Mismatch-repair Deficient or Microsatellite Instability-high Locally Advanced Colorectal Cancer (PICC)","PICC","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Histological or cytological documentation of adenocarcinoma of the colon or rectum.\n3. Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).\n4. Male or female subjects aged 18 to 75 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Determined CT or MRI scans (done within 14 days of registration) of the chest, abdomen and pelvis: locally advanced (cT3-4 or cN1-2 \\[with the definition of a clinically positive lymph node being any node ≥ 1.0 cm\\]).\n7. Non complicated primary tumor (obstruction, perforation, bleeding).\n8. No previous any systemic anticancer therapy for colorectal cancer disease.\n9. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment.\n\nExclusion Criteria:\n\n1. Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization.\n2. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.\n3. Heart failure grade III\u002FIV (NYHA-classification).\n4. Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy\u002Fprocedure.\n5. Subjects with known allergy to the study drugs or to any of its excipients.\n6. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.\n7. Breast- feeding or pregnant women\n8. Lack of effective contraception.\n9. Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody or other drug\u002Fantibody that acts on T cell costimulation or checkpoint pathways.\n10. With any distant metastasis.",{"count":58,"type":21},270,[24],"Colorectal cancer of Mismatch Repair-deficient (dMMR)\u002F Microsatellite Instability-high (MSI-H) accounts for approximately 15% of all colorectal cancer patients, with a higher proportion in right colon cancer. Previous studies have found that colon cancer patients with dMMR\u002FMSI-H cannot benefit from 5-fluorouracil (5-FU) adjuvant chemotherapy. Once patients have distant metastases, they are not sensitive to traditional palliative chemotherapy, and the prognosis is significantly worse than that of mismatch repair-proficient (pMMR)\u002Fmicrosatellite stability (MSS). A phase II clinical study of anti-PD-1 immunotherapy based on mismatch repair (MMR) status published in 《N Engl J Med》 showed that the objective response rate (ORR) of advanced colorectal cancer patients with dMMR received anti-PD-1 is 40%, and a longer response time can be obtained compared to conventional chemotherapy.\n\nAnti-PD-1 neoadjuvant therapy has proven to be safe and feasible in lung cancer, bladder cancer and malignant melanoma, and can achieve more than 40% of major pathological response. However, there are no reports of anti-PD-1 neoadjuvant therapy for the dMMR\u002FMSI-H colorectal cancer. Therefore, the aim of this study was to find the best multidisciplinary treatment for resectable colorectal cancer patient with the dMMR\u002FMSI-H phenotype and to explore whether cyclooxygenase (COX) inhibitors combined with anti-PD-1 monoclonal antibody (mAb) could further improve efficacy.",[62,63,64,65],"Colorectal Cancer","Mismatch Repair-deficient (dMMR)","Microsatellite Instability-high (MSI-H)","Neoadjuvant Therapy","2025-11-17",{"date":68,"type":40},"2025-11-20",{"date":70,"type":40},"2019-05-10",{"date":72,"type":21},"2030-04-01",{"name":74,"class":47},"Sun Yat-sen University"]