[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633502":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":31,"locations":40,"responsibleParty":59,"collaborators":31,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":31,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":31,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":31,"overallStatus":82,"whyStopped":31,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group A","EXPERIMENTAL","CapOx+Serplulimab+Moderately Hypofractionated Radiotherapy",[13],"Drug: Serplulimab",{"label":15,"type":10,"description":16,"interventionNames":17},"Experimental group B","CapOx+Serplulimab+Long-course radiotherapy",[18],"Radiation: Moderately Hypofractionated Radiotherapy",{"label":20,"type":21,"description":22,"interventionNames":23},"Control arm","ACTIVE_COMPARATOR","CapOx+Long-course radiotherapy",[24],"Other: CapOx+Long-course radiotherapy",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"RADIATION","Moderately Hypofractionated Radiotherapy","CapOx Regimen Recommended Dose：Capecitabine: 1000 mg\u002Fm² orally twice daily on days 1-14 of each 21-day cycle.Oxaliplatin: 130 mg\u002Fm² intravenously on day 1 of each 21-day cycle.\n\nSerplulimab: 300 mg intravenously on day 1 of each 21-day cycle. Moderately Hypofractionated Radiotherapy：Delivered using a simultaneous integrated boost (SIB) technique.Gross tumor volume (GTV): 3.5 Gy per fraction; clinical target volume (CTV): 3.0 Gy per fraction.Once daily, 5 fractions per week, for a total of 10 fractions.Total dose: GTV 35 Gy, CTV 30 Gy.",[15],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DRUG","Serplulimab","CapOx Regimen Recommended Dose：Capecitabine: 1000 mg\u002Fm² orally twice daily on days 1-14 of each 21-day cycle.Oxaliplatin: 130 mg\u002Fm² intravenously on day 1 of each 21-day cycle.\n\nSerplulimab: 300 mg intravenously on day 1 of each 21-day cycle. Long-course Concurrent Chemoradiotherapy：Delivered using a conventional fractionation schedule.Gross tumor volume (GTV): 1.8-2.0 Gy per fraction, total dose 50-50.4 Gy.Clinical target volume (CTV): 1.8 Gy per fraction, total dose 45 Gy.Once daily, 5 fractions per week.GTV receives 25-28 fractions; CTV receives 25 fractions.",[9],{"type":6,"name":22,"description":38,"armGroupLabels":39,"otherNames":31},"CapOx Regimen Recommended Dose：Capecitabine: 1000 mg\u002Fm² orally twice daily on days 1-14 of each 21-day cycle.Oxaliplatin: 130 mg\u002Fm² intravenously on day 1 of each 21-day cycle.\n\nLong-course Concurrent Chemoradiotherapy：Delivered using a conventional fractionation schedule.Gross tumor volume (GTV): 1.8-2.0 Gy per fraction, total dose 50-50.4 Gy.Clinical target volume (CTV): 1.8 Gy per fraction, total dose 45 Gy.Once daily, 5 fractions per week.GTV receives 25-28 fractions; CTV receives 25 fractions.",[20],[41],{"facility":42,"status":31,"city":43,"state":31,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Zhongshan hosptial, Fudan University","Shanghai","200032","China","CN",{"type":48,"coordinates":49},"Point",[50,51],121.45806,31.22222,{"lat":51,"lon":50},[54],{"name":55,"role":56,"phone":57,"phoneExt":31,"email":58},"jianming XU, PhD","CONTACT","+86-13501984869","xujmin@aiiyun.com",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Xu jianmin","Chief Physician","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":73,"type":74},165,"ESTIMATED","INTERVENTIONAL",[77],"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.",[80,28,34,81],"Rectal Cancer","pMMR\u002FMSS","NOT_YET_RECRUITING","2026-04-07",{"date":85,"type":86},"2026-04-14","ACTUAL",{"date":88,"type":74},"2026-06",{"date":90,"type":74},"2031-06",{"name":5,"class":6},1]