[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537713":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":43,"centralContacts":47,"locations":56,"responsibleParty":72,"collaborators":33,"id":75,"slug":33,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":33,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":33,"overallStatus":59,"whyStopped":33,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Fudan University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Immunochemotherapy group","EXPERIMENTAL","The patients will receive 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT while a W\\&W option can be applied to patients achieving cCR.",[13,14,15],"Drug: PD-1 inhibitor","Drug: Capecitabine","Drug: Oxaliplatin",{"label":17,"type":10,"description":18,"interventionNames":19},"Radiation plus immunochemotherapy group","The patients will receive short-course radiotherapy (25Gy\u002F5Fx), followed by 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT while a W\\&W option can be applied to patients achieving cCR.",[13,14,20,15],"Radiation: Short-course radiotherapy",[22,29,34,39],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","PD-1 inhibitor","PD-1 inhibitor (Toripalimab): 240mg d1 q3w",[9,17],[28],"Toripalimab",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Capecitabine","Capecitabine: 1000mg\u002Fm2 bid d1-14 q3w",[9,17],null,{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":33},"RADIATION","Short-course radiotherapy","Short-course radiotherapy: 25Gy\u002F5Fx",[17],{"type":23,"name":40,"description":41,"armGroupLabels":42,"otherNames":33},"Oxaliplatin","Oxaliplatin 130mg\u002Fm2 d1 q3w",[9,17],[44],{"name":45,"affiliation":5,"role":46},"Zhen Zhang, MD","PRINCIPAL_INVESTIGATOR",[48,52],{"name":45,"role":49,"phone":50,"phoneExt":33,"email":51},"CONTACT","18801735029","zhen_zhang@fudan.edu.cn",{"name":53,"role":49,"phone":54,"phoneExt":33,"email":55},"Yaqi Wang, MD","18121299593","10301010093@fudan.edu.cn",[57],{"facility":58,"status":59,"city":60,"state":33,"zip":33,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","China","CN",{"type":64,"coordinates":65},"Point",[66,67],121.45806,31.22222,{"lat":67,"lon":66},[70],{"name":71,"role":49,"phone":50,"phoneExt":33,"email":51},"Zhen Zhang, MD, PHD",{"type":46,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Zhen Zhang","Study Principal Investigator","100537713",false,"NCT06281405","CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer","A Prospective Randomized Phase II Trial of CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for Microsatellite Stable Locally Advanced Rectal Cancer (TORCH-iTNT)","TORCH-iTNT","Inclusion Criteria\n\n1. Age 18-70 years old, female and male;\n2. Pathological confirmed adenocarcinoma;\n3. The distance from anal verge ≤ 10 cm;\n4. MSI\u002FMMR status: MSS\u002FpMMR;\n5. Clinical stage T3-4 and\u002For N+, without distance metastases;\n6. At least one of the following factors is present: distance from the anus ≤5 cm, cT4, cN2, positive cMRF, positive cEMVI, or positive lateral lymph nodes;\n7. KPS ≥ 70;\n8. No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;\n9. Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10\\^9\u002FL, Hb ≥ 90 g\u002FL, PLT ≥ 100 × 10\\^9\u002FL, ALT\u002F AST ≤ 2.5 ULN, Cr ≤ 1 ULN;\n10. With good compliance and signed the consent form.\n\nExclusion Criteria\n\n1. Pregnancy or breast-feeding women;\n2. Known history of other malignancies within 5 years;\n3. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);\n4. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;\n5. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;\n6. Uncontrolled infection which needs systemic therapy;\n7. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;\n8. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;\n9. Allergic to any component of the therapy.","ALL","18 Years","70 Years",{"count":86,"type":87},192,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4\u002FN+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy\u002F5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \\[pCR\\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, organ or anal preservation rate, 3-year DFS rate, etc.",[93,94],"Locally Advanced Rectal Cancer","Neoadjuvant Therapy","2026-03-30",{"date":97,"type":98},"2026-04-03","ACTUAL",{"date":100,"type":98},"2024-03-28",{"date":102,"type":87},"2028-12-31",{"name":5,"class":6},1]