[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585553":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":21,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":21,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":21,"enrollmentInfo":69,"targetDuration":21,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":40,"whyStopped":21,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Toripalimab plus celecoxib","EXPERIMENTAL","Toripalimab is administered intravenously at 3 mg\u002Fkg over 30 minutes once every 2 weeks for a total of 12 doses. Celecoxib is administered orally at 200 mg twice daily for 6 months. Patients achieving clinical complete response (cCR) are recommended for non-operative management, whereas patients without cCR are recommended to undergo curative-intent surgery.",[13,14,15],"Drug: Toripalimab plus celecoxib","Procedure: Non-operative management","Procedure: Curative-intent surgery",[17,22,27],{"type":18,"name":9,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Toripalimab is administered intravenously at 3 mg\u002Fkg over 30 minutes once every 2 weeks for a total of 12 doses. Celecoxib is administered orally at 200 mg twice daily for 6 months.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"PROCEDURE","Non-operative management","Patients achieving clinical complete response (cCR) according to comprehensive response assessment, including imaging, endoscopy, digital rectal examination (if applicable), and ctDNA evaluation, may undergo non-operative management.",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":21},"Curative-intent surgery","Patients who do not achieve cCR will undergo curative-intent surgery.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Yanhong Deng, MD.","CONTACT","020-38379762","dengyanh@mail.sysu.edu.cn",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"The Sixth Affiliated Hospital, Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510655","China","CN",{"type":47,"coordinates":48},"Point",[49,50],113.25,23.11667,{"lat":50,"lon":49},[53],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":58,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Yanhong Deng","Professor","Sixth Affiliated Hospital, Sun Yat-sen University","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":70,"type":71},105,"ESTIMATED","INTERVENTIONAL",[74],"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.",[77,78,79],"Colorectal Cancer","Microsatellite Instability High","Mismatch Repair Deficiency",[81,82,83,84,85],"PD-1 blockade","Toripalimab","COX-2 inhibitor","Celecoxib","Non-operative Management","2026-05-20",{"date":88,"type":89},"2026-05-22","ACTUAL",{"date":91,"type":89},"2025-06-01",{"date":93,"type":71},"2031-04-01",{"name":5,"class":6},1]