[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoadjuvant-chemoradiation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoadjuvant-chemoradiation":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100641505",false,"NCT07596290","Yang et al. Anti-PD-1\u002FCTLA-4 Dual Immunotherapy for LARC","Efficacy and Safety of Neoadjuvant Short-Course\u002FLong-Course Radiotherapy Combined With Anti-PD-1\u002FCTLA-4 Dual Immunotherapy for Locally Advanced Rectal Cancer: A Prospective, Randomized Controlled Trial (RADICAL Trial)","RADICAL","Inclusion Criteria:\n\n1. Age between 18 and 80 years; ECOG performance status 0-1;\n2. Histopathologically confirmed rectal adenocarcinoma via colonoscopy; pMMR or MSS phenotype;\n3. Rectal MRI stage II\u002FIII (excluding T4b); distal tumor margin ≤ 12 cm from the anal verge;\n4. Willingness to comply with study procedures; consent to use tissue and blood samples for medical research purposes;\n5. No prior history of radiotherapy, chemotherapy, or immunotherapy;\n6. No immune system diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, hyperthyroidism\u002Fhypothyroidism, ulcerative colitis, autoimmune hemolytic anemia, HIV infection, etc.);\n7. No severe cardiac, pulmonary, hepatic, or renal dysfunction; no jaundice or gastrointestinal obstruction;\n8. No concurrent acute infection;\n9. Baseline laboratory evaluations completed as required, with results obtained within 14 days before randomization, and laboratory values meeting the following criteria (per CTCAE 5.0):\n\n   * White blood cell count ≥ 2000\u002FμL;\n   * Neutrophil count ≥ 1500\u002FμL;\n   * Platelet count ≥ 100×10³\u002FμL;\n   * Hemoglobin ≥ 9.0 g\u002FdL;\n   * Serum creatinine ≤ 1.5×upper limit of normal (ULN) or creatinine clearance \\> 50 mL\u002Fmin (female: creatinine clearance = \\[140 - age (years)\\] × body weight (kg) × 0.85 \u002F (72 × serum creatinine (mg\u002FdL)); male: creatinine clearance = \\[140 - age (years)\\] × body weight (kg) × 1.00 \u002F (72 × serum creatinine (mg\u002FdL)));\n   * AST ≤ 3×ULN, ALT ≤ 3×ULN, total bilirubin ≤ 1.5×ULN;\n10. No psychiatric\u002Fpsychological disorders affecting social function;\n11. Negative serum pregnancy test (blood HCG) within 1 week before randomization for women of childbearing potential;\n12. Women of childbearing potential must agree to use effective contraception during the study period and for 5 months after the last dose of study drug;\n13. Male subjects who are sexually active with women of childbearing potential must agree to use effective contraception during the study period and for 7 months after the last dose of study drug, and must refrain from sperm donation during this period.\n\nExclusion Criteria:\n\n1. Multiple primary cancers or concurrent other malignant tumors;\n2. Patients requiring emergency surgery due to intestinal obstruction, intestinal perforation, gastrointestinal bleeding, etc.;\n3. Factors affecting oral drug absorption (e.g., inability to swallow, nausea\u002Fvomiting, diarrhea, intestinal obstruction, etc.);\n4. Any uncontrolled, severe concomitant diseases;\n5. Hypersensitivity to any component of the study drugs;\n6. Expected survival \\\u003C 5 years for any reason;\n7. Planned or previous organ\u002Fbone marrow transplantation;\n8. Treatment with immunosuppressants or corticosteroids within 1 month before enrollment;\n9. Central nervous system disorders that may impair ability to provide informed consent or comply with study procedures, as determined by the investigator;\n10. Other conditions that may prevent completion of study treatment (e.g., alcoholism, drug addiction, etc.);\n11. Pregnant or breastfeeding women.","ALL","18 Years","80 Years",{"count":20,"type":21},342,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This is a prospective, multicenter, randomized controlled trial aimed at comparing different radiotherapy fractionation regimens combined with sequential dual immunotherapy versus traditional chemoradiotherapy in neoadjuvant treatment for locally advanced rectal cancer (LARC). A total of 342 pMMR\u002FMSS LARC patients will be enrolled and randomly assigned in a 1:1:1 ratio to short-course radiotherapy (5×5Gy) followed by sequential dual immunotherapy (paromlimab + tuvonralimab + CAPEOX), long-course radiotherapy followed by sequential dual immunotherapy, or conventional long-course chemoradiotherapy. The primary endpoint is the complete response rate (pCR + cCR). Secondary endpoints include the proportion of patients adopting the \"watch-and-wait\" strategy, disease-free survival, overall survival, and safety. This study innovatively explores the synergistic mechanism of different radiotherapy fractionations with dual immunotherapy, optimizes the timing of immunotherapy initiation, and constructs a clinical-imaging-pathology multimodal efficacy prediction model, aiming to advance LARC treatment from empirical to precision therapy while achieving organ and function preservation.",[28,29,30],"Locally Advanced Rectal Adenocarcinoma","Neoadjuvant Chemoradiation","Neoadjuvant Immunotherapy",[32,33,34,35,36],"Locally advanced rectal cancer","Neoadjuvant chemoradiation","Anti-PD-1\u002FCTLA-4 Dual Immunotherapy","Short-course radiotherapy","Long-course rediotherapy","NOT_YET_RECRUITING","2026-06-16",{"date":40,"type":41},"2026-06-17","ACTUAL",{"date":43,"type":21},"2026-07-15",{"date":45,"type":21},"2030-12-31",{"name":47,"class":48},"Beijing Friendship Hospital","OTHER",""]