[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609404":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":37,"eligibilityCriteria":38,"healthyVolunteers":33,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":20,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":20,"overallStatus":51,"whyStopped":20,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":20},{"fullName":5,"class":6},"The First Affiliated Hospital of University of Science and Technology of China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TNT-immunity","EXPERIMENTAL","1",[13],"Drug: PD-1",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","PD-1","patients will receive short-course chemotherapy and concurrent PD-1",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Liu Liu, MD","CONTACT","+86 15056017712","zhangxubing26240@163.com",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Liu Liu","Principal Investigator","100609404","phase-2-total-neoadjuvant-therapy-with-pd-1-for-locally-advcancer-rectal-cancer-100609404",false,"NCT07214142","Total Neoadjuvant Therapy With PD-1 for Locally Advcancer Rectal Cancer","Efficacy and Safety of Total Neoadjuvant Chemoradiotherapy Combined With PD-1 Therapy for Locally Advanced Rectal Cancer With High Risk of Recurrence","TNT-Immunity","Inclusion Criteria:\n\n1. Pathologically confirmed rectal adenocarcinoma;\n2. Mid-low rectal cancer, with the lower edge of the tumor located within 12 cm from the anal verge;\n3. Magnetic resonance imaging (MRI) suggests locally advanced rectal cancer (T3 or T4 and M0), accompanied by at least one of the following risk factors: cT4, N2, lymphovascular invasion, involvement of the mesorectal fascia, or enlarged lateral lymph nodes (short-axis diameter \\> 8 mm); patients with potentially resectable disease;\n4. Polymerase chain reaction (PCR) testing indicates microsatellite stability (MSS) type;\n5. No prior antitumor therapy, such as chemotherapy, radiotherapy, immunotherapy, or targeted therapy;\n6. Age between 18 and 75 years;\n7. ECOG Performance Status (PS) score of 0-1;\n8. Laboratory test results: WBC ≥ 3.5 × 10\\^9\u002FL, Hb ≥ 100 g\u002FL, PLT ≥ 100 × 10\\^9\u002FL; normal liver and kidney function;\n9. Absence of severe comorbidities, and ability to tolerate surgical treatment;\n10. The patient or their immediate family member voluntarily agrees to participate in this study and provides written informed consent.\n\nExclusion Criteria:\n\n1. Recurrent rectal cancer;\n2. Synchronous colorectal cancer;\n3. Pregnant or lactating patients;\n4. History of other malignant tumors;\n5. Previous antitumor therapy, including chemotherapy or radiotherapy;\n6. Dysfunction of vital organs such as cardiac or pulmonary insufficiency;\n7. History of autoimmune diseases or immunodeficiency disorders;\n8. Use of immunosuppressive drugs within the past year;\n9. Distant metastasis to organs such as the abdominal cavity, pelvis, liver, or lungs;\n10. Active bleeding;\n11. Tumor involvement of adjacent structures such as the prostate or sacral organs, making the tumor unresectable;\n12. Allergy to chemotherapeutic agents, immune checkpoint inhibitors, or cetuximab;\n13. Psychiatric disorders or lack of capacity for civil conduct, unable to provide informed consent.","ALL","18 Years","75 Years",{"count":43,"type":44},30,"ESTIMATED","INTERVENTIONAL",[47],"PHASE2","Research Objective:To investigate the efficacy and safety of the \"total neoadjuvant chemoradiotherapy combined with immunotherapy\" regimen for the treatment of locally advanced rectal cancer with high-risk features for recurrence.\n\nStudy Design:A single-arm, multicenter clinical study.\n\nStudy Population: Patients with locally advanced rectal cancer presenting with high-risk features for local recurrence.",[50],"Rectal Cancer Patients","NOT_YET_RECRUITING","2025-10-08",{"date":54,"type":55},"2025-10-09","ACTUAL",{"date":57,"type":44},"2025-10-01",{"date":59,"type":44},"2030-12-31",{"name":5,"class":6}]