[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635345":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":46,"locations":52,"responsibleParty":75,"collaborators":28,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":28,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":105,"whyStopped":28,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Fudan University","OTHER",[8,15],{"label":9,"type":6,"description":10,"interventionNames":11},"TNT group","TNT group receives long-course chemoradiotherapy (concurrent with oral capecitabine) followed by 6 cycles of CAPOX.",[12,13,14],"Radiation: long-course chemoradiaothearpy","Drug: Capecitabine","Drug: Oxaliplatin",{"label":16,"type":17,"description":18,"interventionNames":19},"iTNT group","EXPERIMENTAL","iTNT group receives short-course radiotherapy (25Gy\u002F5Fx) followed by 6 cycles of Serplulimab combined with CAPOX.",[20,13,14,21],"Radiation: short-course radiaotherapy","Drug: PD-1 inhibitor",[23,29,33,38,42],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","short-course radiaotherapy","short-course radiaotherapy (25Gy\u002F5Fx)",[16],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"long-course chemoradiaothearpy","long-course chemoradiotherapy (50Gy\u002F25Fx concurrent with oral capecitabine 825mg\u002Fm2 bid d1-5 qw)",[9],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"DRUG","Capecitabine","Capecitabine: 1000mg\u002Fm2 bid d1-14 q3w",[9,16],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Oxaliplatin","Oxaliplatin 130mg\u002Fm2 d1 q3w",[9,16],{"type":34,"name":43,"description":44,"armGroupLabels":45,"otherNames":28},"PD-1 inhibitor","Serplulimab 300mg d1 q3w",[16],[47],{"name":48,"role":49,"phone":50,"phoneExt":28,"email":51},"Zhen Zhang, MD, PhD","CONTACT","18801735029","zhen_zhang@fudan.edu.cn",[53],{"facility":54,"status":28,"city":55,"state":28,"zip":28,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Fudan University Shanghai Cancer Center","Shanghai","China","CN",{"type":59,"coordinates":60},"Point",[61,62],121.45806,31.22222,{"lat":62,"lon":61},[65,66,70,73],{"name":48,"role":49,"phone":50,"phoneExt":28,"email":51},{"name":67,"role":49,"phone":68,"phoneExt":28,"email":69},"Yaqi Wang, MD","18121299593","10301010093@fudan.edu.cn",{"name":71,"role":72,"phone":28,"phoneExt":28,"email":28},"Zhen Zhang, MD PhD","PRINCIPAL_INVESTIGATOR",{"name":74,"role":72,"phone":28,"phoneExt":28,"email":28},"Xinxiang Li, MD, PhD",{"type":72,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Zhen Zhang","Professor","100635345","phase-3-scrt-based-itnt-vs-lcrt-based-tnt-for-mss-locally-advanced-rectal-cancer-100635345",false,"NCT07551479","SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer","SCRT Followed by CAPOX and PD-1 Inhibitor Versus LCCRT Followed by CAPOX in Total Neoadjuvant Treatment for High-risk LARC: A Prospective, Randomized, Multicenter, Phase III Study","TORCH-STAR","Inclusion Criteria\n\n1. Age 18-75 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, positive tumor deposit or positive lateral lymph node;\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","75 Years",{"count":90,"type":91},612,"ESTIMATED","INTERVENTIONAL",[94],"PHASE3","In this prospective, multicentre, randomized phase III trial, 612 locally advanced rectal cancer (LARC, T3-4\u002FN+M0) patients with at least one high-risk features (lower location (≤5cm), cT4, cN2, MRF+, EMVI+, TD+) will be included, and randomly assigned to TNT group and iTNT group (1:1). TNT group receives long-course chemoradiotherapy (50Gy\u002F25Fx concurrent with oral capecitabine) followed by 6 cycles of CAPOX. iTNT group receives short-course radiotherapy (25Gy\u002F5Fx) followed by 6 cycles of Serplulimab combined with CAPOX. After the efficacy evaluation, the patients who achieves clinical complete response (cCR) will be managed by a watch and wait (W\\&W) protocol and non-cCR patients will be recommended surgery. The primary endpoint is 3-year event-free survival rate (3yEFS%). The secondary endpoints include the complete response (CR, pathological complete response \\[pCR\\] plus cCR) rate, 3-year organ preservation rate, 3-year disease-free survival rate (3yDFS%), 3-year local recurrence free survival rate (3yLRFS%), 3-year distant metastasis free survival rate (3yDMFS%), 3-year overall survival rate (3yOS%), grade 3-4 acute adverse effects (AE) rate, rate of surgical complications, anal functions and quality of life, etc.",[97,98],"Locally Advanced Rectal Cancer (LARC)","MSS (Microsatellite Stable)",[100,101,102,103,104],"Total Neoadjuvant Therapy","Immunotherapy","Survival Rate","Organ preservation","Locally advanced rectal cancer","NOT_YET_RECRUITING","2026-04-22",{"date":108,"type":109},"2026-04-24","ACTUAL",{"date":111,"type":91},"2026-05-01",{"date":113,"type":91},"2035-12-31",{"name":5,"class":6},1]