[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jinhua Central Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100531768","phase-2-node-sparing-radiotherapy-combined-with-total-neoadjuvant-capox-and-sintilimab-for-mss-middle-and-low-rectal-cancer-100531768",false,"NCT06204094","Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer","Total Neoadjuvant CAPOX And PD-1 Inhibitor（Sintilimab） Combined With Node-sparing Short-course Radiotherapy For MSS Locally Advanced Of Middle And Low Rectal Cancer(CASINOs): An Open Label, Single-arm, Prospective Clinical Trial","CASINOs","Inclusion Criteria:\n\n* Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.\n* Male or Female aged 18-75.\n* Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT2N+M0\u002FcT3-4N0\u002F+M0, the lymph nodes are limited to the mesorectum.\n* Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.\n* Eastern Cooperative Oncology Group (ECOG) 0-1.\n* No previous treatment(including anti-tumor therapy、immunotherapy or pelvic radiation).\n* Adequate hematologic, hepatic, renal, thyroid and cardiac function: white blood cells ≥3500\u002Fmm3, neutrophils ≥1800\u002Fmm3, platelets ≥100,000\u002Fmm3, hemoglobin ≥100 g\u002FL; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.25 × ULN, serum albumin ≥28 g\u002FL. creatinine clearance ≥50 mL\u002Fmi, creatinine ≤1.5 × ULN;\n* Informed consent form signed.\n\nExclusion Criteria:\n\n* Patients with a previous history of malignant tumors besides rectal cancer.\n* Patients with distant metastases before enrollment.\n* Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT.\n* Patients with obstruction, perforation, or bleeding that require emergency surgery.\n* Patients with severe concomitant diseases and estimated survival time ≤ 5 years.\n* Allergic to any component of the therapy.\n* Patients with poorly differentiated adenocarcinoma, signet ring cell carcinoma, or mucinous adenocarcinoma.\n* Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.\n* Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening.\n* Factors leading to study termination, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) requiring combination therapy, and patients with severe laboratory abnormalities.\n* Patients with congenital or acquired immune deficiency (such as HIV infection).\n* Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc.\n\nOther conditions that investigators consider not suitable for this study.","ALL","18 Years","75 Years",{"count":21,"type":22},37,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.",[28],"Locally Advanced Rectal Cancer",[30,31,32,33,34,35,36,37],"rectal cancer","microsatellite stability","node-sparing","CAPOX","radiotherapy","sintilimab","immunotherapy","neoadjuvant","RECRUITING","2026-04-21",{"date":41,"type":42},"2026-04-24","ACTUAL",{"date":44,"type":42},"2024-02-05",{"date":46,"type":22},"2028-09-01",{"name":48,"class":49},"Jinhua Central Hospital","OTHER",""]