[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571306":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":33,"locations":43,"responsibleParty":64,"collaborators":32,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":32,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":46,"whyStopped":32,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SCRT followed by CapeOX regimen combined with AK112","EXPERIMENTAL","Patients will receive short-course radiotherapy (SCRT) followed by chemotherapy (CapeOX regimen) combined with AK112:\n\nIn the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of CapeOX chemotherapy combined with AK112 (every 3 weeks; Day 1: Oxaliplatin, 130 mg\u002Fm², IV infusion; Day 1: AK112, 20 mg\u002Fkg, IV infusion; Day 1 to Day 14: Capecitabine, 850-1000 mg\u002Fm², BID, orally).",[13],"Drug: AK112 with SCRT and CapeOX",{"label":15,"type":10,"description":16,"interventionNames":17},"SCRT followed by AK112","Patients will receive short-course radiotherapy (SCRT) followed by AK112:\n\nIn the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of AK112 treatment (Day 1: AK112, 20 mg\u002Fkg, IV infusion).",[18],"Drug: AK112 with SCRT",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","AK112 with SCRT and CapeOX","In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7day interval, patients will receive 2 cycles of CapeOX chemotherapy combined with AK112 (every 3 weeks; Day 1: Oxaliplatin, 130 mg\u002Fm², IV infusion; Day 1: AK112, 20 mg\u002Fkg, IV infusion; Day 1 to Day 14: Capecitabine, 850-1000 mg\u002Fm², BID, orally).",[9],[26,27],"short-course radiotherapy","CapeOX",{"type":21,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"AK112 with SCRT","In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of AK112 treatment (Day 1: AK112, 20 mg\u002Fkg, IV infusion).",[15],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Fan LI, PhD","CONTACT","+8618696539200","levinecq@163.com",{"name":40,"role":36,"phone":41,"phoneExt":32,"email":42},"Haode Shen, MD","+8617783437391","imshd@qq.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Daping Hospital","RECRUITING","Chongqing","Chongqing Municipality","400000","China","CN",{"type":53,"coordinates":54},"Point",[55,56],106.55771,29.56026,{"lat":56,"lon":55},[59,61,62],{"name":60,"role":36,"phone":37,"phoneExt":32,"email":38},"Fan Li, PhD",{"name":40,"role":36,"phone":41,"phoneExt":32,"email":42},{"name":60,"role":63,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","fan li","Prof.","100571306","phase-2-neoadjuvant-short-course-radiotherapy-with-or-without-chemotherapy-and-ak112-in-locally-advanced-rectal-cancer-100571306",false,"NCT06718543","Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer","A Multicenter, Randomized, Parallel, Non-Controlled, Prospective Phase II Study of Neoadjuvant Short-Course Radiotherapy Sequential With AK112 With or Without Chemotherapy for Locally Advanced Rectal Cancer","TRIUNITE-03","Inclusion Criteria:\n\n1. Signed written informed consent.\n2. Age 18-80 years, male or female.\n3. Histologically confirmed rectal adenocarcinoma.\n4. Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment.\n5. Able to swallow tablets.\n6. ECOG Performance Status of 0-1.\n7. No prior treatment for rectal cancer, including surgery, radiotherapy, 8.chemotherapy, immunotherapy, or targeted therapy.\n\n9.Fit for surgery with no contraindications. 10.Normal organ function. 11.Tumor ≤12 cm from the anal verge\n\nExclusion Criteria:\n\n1. Allergy to monoclonal antibodies, AK112 components, or CapeOX regimen.\n2. Previous or current use of immune checkpoint inhibitors or immune-related 3.treatments.\n\n4.Active autoimmune diseases or history of significant autoimmune conditions. 5.Immunodeficiency disorders or history of organ\u002Fbone marrow transplantation. 6.Uncontrolled cardiovascular conditions (e.g., heart failure, unstable angina, recent MI).\n\n7.Severe infection within 4 weeks or active pulmonary infections. 8.Active hepatitis B or C infection. 9.Diagnosis of other malignancies within 5 years (except low-risk cancers). 10.Pregnant or breastfeeding women.","ALL","18 Years","80 Years",{"count":80,"type":81},100,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","This phase II multicenter, randomized study evaluates the safety and efficacy of neoadjuvant short-course radiotherapy (SCRT) sequentially combined with AK112 (Envafolimab) with or without chemotherapy in patients with locally advanced rectal cancer (LARC). The study also aims to identify biomarkers predicting tumor response and develop efficacy prediction models.",[87],"Rectal Cancer",[89,90,91,92],"rectal cancer","neoadjuvant","Ivonescimab","Immunotherapy","2025-04-08",{"date":95,"type":96},"2025-04-10","ACTUAL",{"date":98,"type":96},"2025-02-10",{"date":100,"type":81},"2027-10-31",{"name":66,"class":6},1]