[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629027":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":53,"centralContacts":59,"locations":69,"responsibleParty":123,"collaborators":29,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":29,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":29,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":149,"whyStopped":29,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Fujian Cancer Hospital","OTHER_GOV",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Modified Short-course radiotherapy Combined with CAPOX plus Tislelizumab","EXPERIMENTAL","Modified Short-course radiotherapy (GTV-P: 30 Gy\u002F5f , CTV-P: 22.5 Gy\u002F5 f),followed by Oxaliplatin ,Capecitabine and Tislelizumab q3w \\*4 cycles.Efficacy and surgery were assessed after the end of treatment.",[13,14,15,16],"Radiation: Modified Short-course radiotherapy","Drug: Oxaliplatin","Drug: Capecitabine","Drug: Tislelizumab",{"label":18,"type":19,"description":20,"interventionNames":21},"Long-course radiotherapy Combined with Capecitabine and Tislelizumab","ACTIVE_COMPARATOR","Long-course radiotherapy (50.4 Gy\u002F25 f) with concurrent Capecitabine (on radiation days) and Tislelizumab (q3w, 3cycles).Efficacy and surgery were assessed after the end of treatment.",[22,15,16],"Radiation: Long-course radiotherapy",[24,30,34,39,43,47,50],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"RADIATION","Modified Short-course radiotherapy","Rectal lesion + metastatic lymph nodes, GTV 30Gy\u002F5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy\u002F5Fx.",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Long-course radiotherapy","Rectal lesion + metastatic lymph nodes+pelvic lymphatic drainage area,50.4 Gy\u002F25 f",[18],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"DRUG","Oxaliplatin","130 mg\u002Fm²,d1, q3w ,4 cycles",[9],{"type":35,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"Capecitabine","1000 mg\u002Fm, d1-14,bid,q3w, 4 cycles",[9],{"type":35,"name":44,"description":45,"armGroupLabels":46,"otherNames":29},"Tislelizumab","200mg,d1,q3w,4 cycles",[9],{"type":35,"name":40,"description":48,"armGroupLabels":49,"otherNames":29},"825 mg\u002Fm² ,BID ,on radiation days",[18],{"type":35,"name":44,"description":51,"armGroupLabels":52,"otherNames":29},"200mg,d1,q3w,3 cycles",[18],[54,57],{"name":55,"affiliation":5,"role":56},"Jiunluan Li, MD","PRINCIPAL_INVESTIGATOR",{"name":58,"affiliation":5,"role":56},"Chunkang Yang, MD",[60,66],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},"Jinluan Li, MD","CONTACT","15159628678","+86","lijinluan@fjmu.edu.cn",{"name":58,"role":62,"phone":67,"phoneExt":64,"email":68},"13509333116","chunk330@163.com",[70,91,110],{"facility":5,"status":29,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Fuzhou","Fujian","350014","China","CN",{"type":77,"coordinates":78},"Point",[79,80],119.30611,26.06139,{"lat":80,"lon":79},[83,86,88,90],{"name":61,"role":62,"phone":84,"phoneExt":29,"email":85},"+86-15959628678","lijinluan@fjmuedu.cn",{"name":58,"role":62,"phone":87,"phoneExt":29,"email":68},"+86-13509333116",{"name":89,"role":56,"phone":29,"phoneExt":29,"email":29},"Jinluan Li, MD,PhD",{"name":58,"role":56,"phone":29,"phoneExt":29,"email":29},{"facility":92,"status":29,"city":93,"state":72,"zip":94,"country":74,"countryCode":75,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"The Second Hospital of Longyan","Longyan","364000",{"type":77,"coordinates":96},[97,98],117.01775,25.07485,{"lat":98,"lon":97},[101,105,108],{"name":102,"role":62,"phone":103,"phoneExt":29,"email":104},"Ping Lin","+86-139 5909 4969","stone3166@126.com",{"name":106,"role":107,"phone":29,"phoneExt":29,"email":29},"Hongsheng He","SUB_INVESTIGATOR",{"name":109,"role":107,"phone":29,"phoneExt":29,"email":29},"Jihuang Wang",{"facility":111,"status":29,"city":112,"state":72,"zip":113,"country":74,"countryCode":75,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Jinjiang Municipal Hospital","Quanzhou","362200",{"type":77,"coordinates":115},[116,117],118.58583,24.91389,{"lat":117,"lon":116},[120],{"name":121,"role":62,"phone":122,"phoneExt":29,"email":29},"Yixiang Zhuang, MD","+86 18876539839",{"type":124,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100629027","phase-2-short-course-rt-plus-capox-and-tislelizumab-vs-long-course-crt-plus-tislelizumab-for-locally-advanced-rectal-cancer-100629027",false,"NCT07469306","Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer","Prospective, Randomized, Phase II Trial of Modified Short-Course Radiotherapy Plus CAPOX and Tislelizumab Versus Long-Course Chemoradiotherapy Plus Tislelizumab for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Age 18-75 years, any gender.\n* Pathologically confirmed rectal adenocarcinoma.\n* Baseline MR stage T3-4\u002FN+.\n* Distance from anal verge ≤12cm.\n* No distant metastasis.\n* Karnofsky Performance Status ≥70.\n* Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy.\n* Microsatellite\u002Fmismatch repair status MSS\u002FpMMR.\n* No prior chemotherapy or any other anti-tumor treatment before inclusion.\n* No prior immunotherapy.\n* Ability to comply with the study protocol during the study period.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Pathological diagnosis of signet ring cell carcinoma.\n* History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.\n* Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.\n* Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.\n* Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.\n* Patients with autoimmune diseases.\n* Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.\n* Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g\u002FL; absolute neutrophil count (ANC) .≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; ALT, AST ≤2.5 times the upper limit of normal; ALP\n\n  ≤2.5 times the upper limit of normal; serum total bilirubin \\\u003C1.5 times the upper limit of normal; serum creatinine \\\u003C1 times the upper limit of normal; serum albumin ≥30g\u002FL.\n* Known deficiency of dihydropyrimidine dehydrogenase (DPD).\n* Allergy to any investigational drug components.","ALL","18 Years","75 Years",{"count":136,"type":137},130,"ESTIMATED","INTERVENTIONAL",[140],"PHASE2","To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.",[143],"Locally Advanced Rectal Cancer",[145,146,147,148],"Modified Short-course radiotherapy (mSCRT)","Long-course radiotherapy (LCRT)","CAPOX","PD-1 monoclonal antibody","NOT_YET_RECRUITING","2026-03-10",{"date":152,"type":153},"2026-03-13","ACTUAL",{"date":155,"type":137},"2026-08-10",{"date":157,"type":137},"2027-09-01",{"name":5,"class":6},3]