[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microsatellite-instability-high\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microsatellite-instability-high":76},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"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},"100585553","phase-2-toripalimab-plus-celecoxib-for-dmmrmsi-h-locally-advanced-colorectal-cancer-100585553",false,"NCT06903858","Toripalimab Plus Celecoxib for dMMR\u002FMSI-H Locally Advanced Colorectal Cancer","Toripalimab Plus Celecoxib With Response-adapted Non-operative Management for Mismatch Repair-deficient or Microsatellite Instability-high Locally Advanced Colorectal Cancer (PICC-3): a Multicenter, Single-arm, Phase 2 Trial","PICC-3","Inclusion Criteria:\n\n1. Signed informed consent and willingness\u002Fcompliance with study procedures.\n2. Age ≥18 years.\n3. Histologically confirmed colorectal adenocarcinoma.\n4. ECOG performance status 0-1.\n5. Locally advanced primary tumor (T3\u002FT4 and\u002For N+) confirmed by CT\u002FMRI (pelvic MRI for rectal cancer).\n6. dMMR (IHC) or MSI-H (PCR) status.\n7. No prior anti-cancer therapy for colonrectal cancer (surgery\u002Fchemotherapy\u002Ftargeted therapy\u002Fradiation).\n8. Adequate organ function\n9. For women of childbearing potential: negative pregnancy test and contraception use during and for 3 months post-treatment. Male participants with fertile partners must use contraception.\n10. Willingness to adhere to study requirements.\n\nExclusion Criteria:\n\n1. Presence of distant metastases (M1) confirmed by CT\u002FMRI or PET-CT (at least covering the chest, abdomen, and pelvis).\n2. Complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery.\n3. Inability to achieve complete resection of the primary colorectal tumor.\n4. History or concurrent active malignancy (except malignancies cured ≥5 years ago or adequately treated carcinoma in situ).\n5. Prior treatment with anti-PD-1\u002FPD-L1 antibodies, anti-CTLA-4 antibodies, or other drugs\u002Fantibodies targeting T-cell co-stimulation or checkpoint pathways.\n6. Major surgery (e.g., laparotomy, thoracotomy, organ resection via laparoscopy) or severe trauma within 4 weeks before enrollment (surgical incision must be fully healed).\n7. Thromboembolic events (e.g., cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis) within 12 months before enrollment.\n8. Active coronary artery disease, severe\u002Funstable angina, or newly diagnosed angina\u002Fmyocardial infarction within 12 months before enrollment.\n9. New York Heart Association (NYHA) Class II or higher congestive heart failure (see Appendix 3).\n10. HIV infection, AIDS, or untreated active hepatitis (HBV-DNA ≥500 IU\u002FmL; HCV-RNA above detection limit).\n11. Active inflammatory bowel disease or other colorectal disorders causing chronic diarrhea.\n12. Active, known, or suspected autoimmune disease (exceptions: stable conditions like type 1 diabetes, hypothyroidism on hormone replacement, or skin disorders without systemic treatment, e.g., vitiligo, psoriasis, alopecia).\n13. Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia).\n14. Residual toxicity ≥Grade 2 (per CTCAE v5.0) from prior therapies (except anemia, alopecia, skin pigmentation).\n15. Known or suspected hypersensitivity to any study-related drugs.\n16. Pregnancy or lactation.\n17. Women of childbearing potential (last menstruation \\\u003C2 years ago) or fertile men unwilling to use effective non-hormonal contraception.\n18. Any unstable medical condition compromising safety or protocol compliance.","ALL","18 Years",{"count":20,"type":21},105,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The PICC-3 study is a multicentre, single-arm, phase II trial evaluating toripalimab plus celecoxib in patients with mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) locally advanced colorectal cancer. The trial uses a response-adapted treatment strategy, whereby patients with clinical complete response (cCR) after therapy may enter a non-operative management pathway, while patients without cCR proceed to surgery. Response assessment is based on imaging, endoscopy, biopsy evaluation, and ctDNA analysis.",[27,28,29],"Colorectal Cancer","Microsatellite Instability High","Mismatch Repair Deficiency",[31,32,33,34,35],"PD-1 blockade","Toripalimab","COX-2 inhibitor","Celecoxib","Non-operative Management","RECRUITING","2026-05-20",{"date":39,"type":40},"2026-05-22","ACTUAL",{"date":42,"type":40},"2025-06-01",{"date":44,"type":21},"2031-04-01",{"name":46,"class":47},"Sun Yat-sen University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":48},"100556099","phase-3-adjuvant-pd-1-blockade-for-high-risk-stage-ii-dmmrmsi-h-colorectal-cancer-100556099","NCT06520683","Adjuvant PD-1 Blockade for High-risk Stage-II DMMR\u002FMSI-H Colorectal Cancer","Short-course PD-1 Blockade As Adjuvant Treatment for High-risk Stage-II DMMR\u002FMSI-H Colorectal Cancer","SMALLER","Inclusion Criteria:\n\n* dMMR and\u002For MSI-H colorectal carcinoma that undergo surgical resection\n* Pathologically confirmed as stage II (T3-4,N0), with at least one of the following risk factors: 1) T4 (including T4a and T4b); 2) Vascular invasion; 3) Perineural invasion; 4) Poor differentiation (including mucinous and signet-ring carcinoma); 5) Obstruction and\u002For perforation before surgery.\n* Perioperative CT\u002FMR\u002FPET-CT find no signs of metastases\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start\n* Aged 18-80\n* No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for the current cancer\n* Adequate organ function\n\nExclusion Criteria:\n\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* Positive surgical margin (R1\u002FR2 resection)\n* Presence of post-operative complications that may preclude treatment\n* Active infection requiring systemic therapy\n* Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk \\\u003C5%.","80 Years",{"count":59,"type":21},180,[61],"PHASE3","This open-label phase III trial investigates the efficacy of two cycles of PD-1 blockade (Tislelizumab) as adjuvant therapy to see how it works compared with standard of care (SOC) in treating patients with stage II dMMR\u002FMSI-H colorectal cancer.\n\nThe rational of giving PD-1 blockade as adjuvant therapy is based on the fact that tumor recurrence is extremely low among patients receiving neoadjuvant immunotherapy, which suggests that PD-1 blockade may likely improve patients' long-term survival.\n\nAs for the short course (two cycles), we have the following considerations: firstly, the NICHE-2 trial, which adopted a two-cycle regimen, reported no recurrences during follow-up, suggesting that short-course anti-PD-1 therapy may be sufficient to improve the survival of patients with localized dMMR\u002FMSI-H colorectal cancer. Secondly, the potential benefits of PD-1 blockade should be balanced against its toxicities, because patients with stage-II dMMR colorectal cancer generally have a good prognosis. Two cycles of PD-1 blockade have been shown to have a good safety profile, with low incidence of grade 3-4 and immune-related adverse events.",[27,28],[65,66,67,31],"Adjuvant therapy","Stage II CRC","dMMR\u002FMSI-H","2024-11-05",{"date":70,"type":40},"2024-11-07",{"date":72,"type":40},"2024-11-01",{"date":74,"type":21},"2030-11-01",{"name":46,"class":47},"Microsatellite Instability-High"]