[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657210":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":37,"armGroups":44,"interventions":54,"overallOfficials":37,"centralContacts":73,"locations":79,"responsibleParty":93,"collaborators":37,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":37,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":37,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":37,"overallStatus":116,"whyStopped":37,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Fudan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"complete response (CR) rate","Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\\&W strategy.","From date of receiving neoadjuvant therapy, assessed up to 2 years",[14,17,21,25,29,33],{"measure":15,"description":16,"timeFrame":12},"Organ preservation rate","Rate of patients who underwent organ preservation via WW or TEM after neoadjuvant therapy",{"measure":18,"description":19,"timeFrame":20},"3 year disease free survival rate","Rate of 3 year disease free survival","From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months",{"measure":22,"description":23,"timeFrame":24},"3 year local recurrence free survival rate","Rate of 3 year local recurrence free survival","From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.",{"measure":26,"description":27,"timeFrame":28},"3 year overall survival rate","Rate of 3 year overall survival","From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.",{"measure":30,"description":31,"timeFrame":32},"10 year Quality of Life","Patient self-assessment via EORTC QLQ-C30 questionnaire to monitor changes in quality of life throughout treatment.","From date of initiation of treatment until the date of death from any cause, assessed up to 10 years",{"measure":34,"description":35,"timeFrame":36},"Grade 3-4 adverse effects rate","Incidence and severity of treatment side effects graded by NCI CTCAE v5.0.","From date of initiation of treatment until the date of death from any cause, assessed up to 5 years",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"NA","SINGLE_GROUP","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE",[45],{"label":46,"type":47,"description":48,"interventionNames":49},"Treatment Arm","EXPERIMENTAL","A total of 34 patients will receive 5\\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1\u002FCTLA4 antibody, finally receive the TEM or TME surgery.",[50,51,52,53],"Radiation: Shor-course radiotherapy","Drug: PD-1\u002FCTLA4 Antibody","Drug: Capecitabine","Drug: Oxaliplatin",[55,60,65,69],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":37},"RADIATION","Shor-course radiotherapy","Shor-course radiotherapy: 25Gy\u002F5Fx",[46],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":37},"DRUG","PD-1\u002FCTLA4 Antibody","Iparomlimab and Tuvonralimab, 5mg\u002Fkg, d1 q3w",[46],{"type":61,"name":66,"description":67,"armGroupLabels":68,"otherNames":37},"Capecitabine","Capecitabine: 1000mg\u002Fm2 d1-14 q3w",[46],{"type":61,"name":70,"description":71,"armGroupLabels":72,"otherNames":37},"Oxaliplatin","130mg\u002Fm2 d1 q3w",[46],[74],{"name":75,"role":76,"phone":77,"phoneExt":77,"email":78},"Zhen Zhang, M.D, PH.D","CONTACT","18801735029","zhen_zhang@fudan.edu.cn",[80],{"facility":81,"status":37,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":37},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200030","China","CN",{"type":88,"coordinates":89},"Point",[90,91],121.45806,31.22222,{"lat":91,"lon":90},{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Zhen Zhang","Professor","100657210","phase-2-scrt-combined-with-capox-and-pd-1ctla4-antibody-for-early-stage-low-rectal-cancer-100657210",false,"NCT07837362","SCRT Combined With CAPOX and PD-1\u002FCTLA4 Antibody for Early-stage Low Rectal Cancer","The Combination of PD-1\u002FCTLA4 Antibody and Neoadjuvant Short-course Radiotherapy in Early-stage Low Rectal Cancer","Inclusion Criteria:\n\n1. age 18-75 years old, female and male\n2. pathological confirmed adenocarcinoma\n3. clinical stage T1-3bN0, tumor maximum diameter less than 4cm\n4. the distance from anal verge less than 5 cm\n5. without distance metastases\n6. KPS \\>=70\n7. with good compliance\n8. microsatellite repair status is MSS\u002FpMMR\n9. without previous anti-cancer therapy or immunotherapy\n10. signed the inform consent\n\nExclusion Criteria:\n\n1. pregnancy or breast-feeding women\n2. pathological confirmed signet ring cell carcinoma\n3. clinical stage T1N0 and can be resected locally\n4. history of other malignancies within 5 years\n5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.\n6. immunodeficiency disease or long-term using of immunosuppressive agents\n7. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\\^9\u002FL, Hb≥90g\u002FL, PLT≥100×10\\^9\u002FL, ALT\u002FAST ≤2.5 ULN, Cr≤ 1 ULN\n8. DPD deficiency\n9. allergic to any component of the therapy","ALL","18 Years","75 Years",{"count":108,"type":109},34,"ESTIMATED","INTERVENTIONAL",[112],"PHASE2","The study evaluates the combination of immunotherapy of PD-1\u002F CTLA4 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5\\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1\u002F CTLA4 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.",[115],"Early Low Rectal Cancer","NOT_YET_RECRUITING","2026-09-17",{"date":119,"type":120},"2026-09-23","ACTUAL",{"date":122,"type":109},"2026-09-01",{"date":124,"type":109},"2028-12-31",{"name":5,"class":6},1]