[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"serplulimab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:serplulimab":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100633502","phase-2-neoadjuvant-moderately-hypofractionated-radiotherapy-combined-with-chemotherapy-and-immunotherapy-for-high-risk-pmmrmss-locally-advanced-rectal-cancer-a-prospective-multi-center-randomized-control-phase-ii-trial-100633502",false,"NCT07527520","Neoadjuvant Moderately Hypofractionated Radiotherapy Combined With Chemotherapy and Immunotherapy for High-risk pMMR\u002FMSS Locally Advanced Rectal Cancer: A Prospective, Multi-center Randomized Control Phase II Trial","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 75 years.\n* Histologically confirmed colorectal adenocarcinoma with the lower margin of the lesion ≤ 10 cm from the anal verge as assessed by MRI, and immunohistochemistry confirming pMMR, or genetic testing demonstrating MSI-L or MSS.\n* Presence of at least one of the following high-risk factors as assessed by pelvic MRI: cT4a\u002Fb; N2; extramural vascular invasion (EMVI+); mesorectal fascia involvement (MRF+); enlarged lateral lymph node (longest diameter \\> 7 mm).\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1\n* No prior surgery, radiotherapy, chemotherapy, or targeted therapy.\n* Able to tolerate radiotherapy, chemotherapy, and immunotherapy: ECOG performance status score 0-2. Laboratory results: white blood cell count ≥ 4.0 × 10⁹\u002FL, platelet count ≥ 100 × 10⁹\u002FL, hemoglobin ≥ 80 g\u002FL, ALT \\\u003C 2 × ULN, total bilirubin \\\u003C 35 μmol\u002FL, serum creatinine \\\u003C 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin, thyroid-stimulating hormone within normal range (patients with stable thyroid function after hormone replacement therapy may be enrolled).\n* Willing to participate and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of distant metastasis.\n* Patients with stage I or II rectal cancer who do not require preoperative neoadjuvant therapy.\n* Severe diseases involving the heart, lung, brain, kidney, gastrointestinal tract, or other systemic conditions.\n* Untreated chronic hepatitis B or HBV carriers with HBV DNA \\> 500 IU\u002FmL, or patients positive for HCV RNA. Patients with inactive hepatitis B surface antigen (HBsAg) carriers, those with hepatitis B who have been treated and are stable (HBV DNA \\\u003C 500 IU\u002FmL), and those who have been cured of hepatitis C may be enrolled.\n* Active autoimmune disease or history of autoimmune disease with potential for relapse.\n* Receipt of corticosteroids (at a dose equivalent to prednisone \\> 10 mg\u002Fday) or other immunosuppressive therapy within 2 weeks prior to study drug administration.\n* History of thyroid dysfunction.\n* Severe chronic or active infection requiring systemic antifungal or antiviral therapy, including tuberculosis infection.\n* History of allergic constitution or allergy to multiple drugs.\n* History of prior pelvic radiotherapy.\n* History of inflammatory bowel disease.\n* Unwillingness to participate or inability to provide written informed consent.","ALL","18 Years","75 Years",{"count":19,"type":20},165,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study aims to observe and evaluate the efficacy and safety of moderately hypofractionated radiotherapy combined with chemotherapy and immunotherapy, compared with conventional neoadjuvant chemoradiotherapy, in patients with high-risk locally advanced colorectal cancer.",[26,27,28,29],"Rectal Cancer","Moderately Hypofractionated Radiotherapy","Serplulimab","pMMR\u002FMSS","NOT_YET_RECRUITING","2026-04-07",{"date":33,"type":34},"2026-04-14","ACTUAL",{"date":36,"type":20},"2026-06",{"date":38,"type":20},"2031-06",{"name":40,"class":41},"Fudan University","OTHER"]