[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574533":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":20,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":20,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":20,"overallStatus":50,"whyStopped":20,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":20},{"fullName":5,"class":6},"The First Affiliated Hospital of Zhengzhou University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ivonescimab+chemotherapy","EXPERIMENTAL","Local advanced rectal cancer with short-course radiotherapy followed by sequential chemotherapy and ivonescimab",[13],"Drug: Ivonescimab (SMT112 or AK112) Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Ivonescimab (SMT112 or AK112) Injection","Eligible subjects will receive short-course radiotherapy (SCRT), 25Gy\u002F5f\u002F1 week. 1-2 weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK112 20 mg\u002Fkg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 850-1000mg\u002Fm2, bid, po, d1-14, oxaliplatin: 130mg\u002Fm2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Yugui Lian, M.D","CONTACT","+86 0371-66279076","fcclianyg@zzu.edu.cn",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Yugui Lian","Clinical Professor","100574533","phase-2-short-course-radiotherapy-followed-by-capox-and-ivonescimab-for-locally-advanced-rectal-cancer-100574533",false,"NCT06760520","Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal Cancer","A Single-arm, Prospective, Phase II Clinical Study of Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Low-middle Rectal Cancer with a High Risk of Recurrence","Inclusion Criteria:\n\n* ECOG score of 0-1;\n* histologically or cytologically confirmed colorectal adenocarcinoma with non-distant metastasis\n* Tumor distance from anal verge ≦10cm\n* at least one high-risk criterion defined by pelvic MRI: cT stage \\>T2 (tumor invades intrinsic muscularis propria by more than 5 mm); Extramural vascular invasion; cN2; Involvement of the rectal mesorectal fascia (tumor or lymph node ≤1mm from the rectal mesorectal fascia); Lateral lymph node short diameter ≥5mm\n* enough organ function\n\nExclusion Criteria:\n\n* with known MSI-H or dMMR\n* Multiple primary adenocarcinomas\n* History of pelvic radiotherapy\n* Previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immunocellular therapy, and other treatments targeting the immune mechanism of the tumor.","ALL","18 Years","75 Years",{"count":42,"type":43},40,"ESTIMATED","INTERVENTIONAL",[46],"PHASE2","This study is a single-arm, prospective, phase II clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with ivonescimab and chemotherapy + total mesorectal excision(TME) surgery in patients with advanced rectal cancer.",[49],"Locally Advanced Rectal Cancer","NOT_YET_RECRUITING","2025-01-06",{"date":53,"type":54},"2025-01-08","ACTUAL",{"date":56,"type":43},"2025-01-20",{"date":58,"type":43},"2031-12-20",{"name":5,"class":6}]