[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571306":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":53,"studyPopulation":46,"armGroups":54,"interventions":66,"overallOfficials":46,"centralContacts":79,"locations":89,"responsibleParty":110,"collaborators":46,"id":114,"slug":46,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":115,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":46,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":92,"whyStopped":46,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"Complete Response Rate","Proportion of patients achieving either a pathological complete response (pCR) or a clinical complete response (cCR).","From treatment initiation to post-neoadjuvant therapy evaluation (approximately 12 weeks).",[14,18,22,26,30,33,37,40,43],{"measure":15,"description":16,"timeFrame":17},"Adverse Events (AEs)","Incidence, type, and severity of adverse events graded according to CTCAE v5.0, including their correlation with the study drug.","From baseline to 90 days after the last treatment dose.",{"measure":19,"description":20,"timeFrame":21},"Major Pathological Response (MPR)","Proportion of patients with ≤10% residual viable tumor cells in resected specimens.","At the time of surgery (approximately 12 weeks after treatment initiation).",{"measure":23,"description":24,"timeFrame":25},"Objective Response Rate (ORR)","Proportion of patients with complete response (CR) or partial response (PR) based on radiological assessments using RECIST 1.1 criteria.","Approximately 12 weeks after treatment initiation.",{"measure":27,"description":28,"timeFrame":29},"Progression-Free Survival (PFS)","Time from randomization to disease progression or death from any cause.","Up to 36 months post-randomization.",{"measure":31,"description":32,"timeFrame":29},"Overall Survival (OS)","Time from randomization to death from any cause.",{"measure":34,"description":35,"timeFrame":36},"Organ Preservation Rate (OPR)","Proportion of patients avoiding major surgery while retaining organ functionality.","Approximately 12 months post-treatment initiation.",{"measure":38,"description":39,"timeFrame":25},"Tumor Response Based on RECIST 1.1","Evaluation of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) using RECIST 1.1 criteria.",{"measure":41,"description":42,"timeFrame":25},"Clinical Complete Response Rate (cCR)","Proportion of patients achieving clinical complete response based on clinical examination and imaging assessments.",{"measure":44,"description":45,"timeFrame":25},"Pathological Complete Response (pCR)","Absence of tumor cells in the primary tumor and regional lymph nodes in surgical specimens.",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":46,"primaryPurpose":50,"observationalModel":46,"timePerspective":46,"maskingInfo":51},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":52,"maskingDescription":46,"whoMasked":46},"NONE","The study is designed as a two-arm, randomized, open-label, prospective trial. Patients with locally advanced rectal adenocarcinoma will be randomly assigned to one of two treatment groups:\n\nArm A: SCRT followed by chemotherapy (CapeOX) combined with AK112. Arm B: SCRT followed by AK112 alone. Primary and secondary outcome measures include complete response rate (CR), safety, pathological and radiological response rates, and biomarkers associated with treatment response. The trial will enroll 100 participants across multiple centers over three years.",[55,61],{"label":56,"type":57,"description":58,"interventionNames":59},"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).",[60],"Drug: AK112 with SCRT and CapeOX",{"label":62,"type":57,"description":63,"interventionNames":64},"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).",[65],"Drug: AK112 with SCRT",[67,75],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"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).",[56],[73,74],"short-course radiotherapy","CapeOX",{"type":68,"name":76,"description":77,"armGroupLabels":78,"otherNames":46},"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).",[62],[80,85],{"name":81,"role":82,"phone":83,"phoneExt":46,"email":84},"Fan LI, PhD","CONTACT","+8618696539200","levinecq@163.com",{"name":86,"role":82,"phone":87,"phoneExt":46,"email":88},"Haode Shen, MD","+8617783437391","imshd@qq.com",[90],{"facility":91,"status":92,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"Daping Hospital","RECRUITING","Chongqing","Chongqing Municipality","400000","China","CN",{"type":99,"coordinates":100},"Point",[101,102],106.55771,29.56026,{"lat":102,"lon":101},[105,107,108],{"name":106,"role":82,"phone":83,"phoneExt":46,"email":84},"Fan Li, PhD",{"name":86,"role":82,"phone":87,"phoneExt":46,"email":88},{"name":106,"role":109,"phone":46,"phoneExt":46,"email":46},"PRINCIPAL_INVESTIGATOR",{"type":111,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"SPONSOR_INVESTIGATOR","fan li","Prof.","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":125,"type":126},100,"ESTIMATED","INTERVENTIONAL",[129],"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.",[132],"Rectal Cancer",[134,135,136,137],"rectal cancer","neoadjuvant","Ivonescimab","Immunotherapy","2025-04-08",{"date":140,"type":141},"2025-04-10","ACTUAL",{"date":143,"type":141},"2025-02-10",{"date":145,"type":126},"2027-10-31",{"name":112,"class":6},1]