[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"early-low-rectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:early-low-rectal-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},34,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Early Low Rectal Cancer","NOT_YET_RECRUITING","2026-09-17",{"date":31,"type":32},"2026-09-23","ACTUAL",{"date":34,"type":21},"2026-09-01",{"date":36,"type":21},"2028-12-31",{"name":38,"class":39},"Fudan University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":40},"100481966","phase-2-the-combination-of-immunotherapy-and-neoadjuvant-short-course-radiotherapy-in-early-rectal-cancer-100481966","NCT05555888","The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer","A Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer","TORCH-E","Inclusion Criteria:\n\n1. age 18-70 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","70 Years",{"count":20,"type":21},[24],"The study evaluates the combination of immunotherapy of PD-1 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 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.",[27],"RECRUITING","2025-01-13",{"date":57,"type":32},"2025-01-15",{"date":59,"type":32},"2022-12-12",{"date":61,"type":21},"2025-05-01",{"name":38,"class":39},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":40},"100551589","phase-2-short-course-radiotherapy-combined-with-capox-and-pd-1-antibody-versus-long-course-chemoradiotherapy-combined-with-capox-for-early-low-lying-rectal-cancer-100551589","NCT06462053","Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer","A Prospective, Randomized, Phase II Trial of Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer","TORCH-E2","Inclusion Criteria:\n\n1. age 18-75 years old, female and male\n2. pathological confirmed adenocarcinoma\n3. clinical stage T1-3bN0-1, 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",{"count":72,"type":21},134,[24],"TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b\u002FN0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy\u002F5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy\u002F25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve 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, anal preservation rate, 3-year DFS rate, etc.",[27],"2024-06-12",{"date":78,"type":32},"2024-06-17",{"date":80,"type":32},"2024-04-01",{"date":82,"type":21},"2027-03-01",{"name":38,"class":39}]