[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531768":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":54,"locations":64,"responsibleParty":83,"collaborators":25,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":25,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Jinhua Central Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm","EXPERIMENTAL","Participants will receive 5\\*5Gy node-sparing short-course radiation (radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) concurrently with total neoadjuvant CAPOX and sintilimab regimens: Oxaliplatin, 130mg\u002Fm2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg\u002Fm2, PO, BID, d1-14 and sintilimab, 200mg intravenous infusion d1 of each cycle. CAPOX and sintilimab are repeated every 3 weeks for 6 cycles. Patients with cCR will be managed with a WW strategy, and patients who did not achieve cCR will receive TME surgery.\n\nInterventions:\n\n* Radiation: node-sparing short-course radiation\n* Drug: PD-1 antibody (Sintilimab)\n* Drug: Capecitabine\n* Drug: Oxaliplatin",[13,14,15,16,17,18],"Radiation: node-sparing short-course radiotherapy","Drug: Sintilimab","Drug: Capecitabine","Drug: Oxaliplatin","Procedure: TME surgery","Procedure: watch and wait",[20,26,33,37,41,48],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","node-sparing short-course radiotherapy","5Gy\\*5d, radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Sintilimab","200mg intravenous infusion d1 of each cycle\\*6cycles",[9],[32],"IBI308",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":25},"Capecitabine","1000mg\u002Fm2, PO, BID, d1-14 of each cycle\\*6cycles",[9],{"type":27,"name":38,"description":39,"armGroupLabels":40,"otherNames":25},"Oxaliplatin","130mg\u002Fm2, intravenous infusion,d1 of each cycle\\*6cycles",[9],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"PROCEDURE","TME surgery","laparoscopic or robotic TME surgery for non-cCR patients",[9],[47],"total mesorectal excision",{"type":42,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"watch and wait","WW for cCR patients",[9],[53],"WW",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":25,"email":59},"jinlin du, master","CONTACT","86 13957998111","djl9090@163.com",{"name":61,"role":57,"phone":62,"phoneExt":25,"email":63},"cheng cai, master","86 18395995912","ColoSurg_cc@zju.edu.cn",[65],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Zhejiang University Affiliated Jinhua Hospital","RECRUITING","Jinhua","Zhejiang","0579","China","CN",{"type":74,"coordinates":75},"Point",[76,77],119.64421,29.10678,{"lat":77,"lon":76},[80],{"name":81,"role":57,"phone":82,"phoneExt":25,"email":63},"Cheng Cai, master degree","86+18395995912",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Cheng Cai","Clinical Professor","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":99,"type":100},37,"ESTIMATED","INTERVENTIONAL",[103],"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.",[106],"Locally Advanced Rectal Cancer",[108,109,110,111,112,113,114,115],"rectal cancer","microsatellite stability","node-sparing","CAPOX","radiotherapy","sintilimab","immunotherapy","neoadjuvant","2026-04-21",{"date":118,"type":119},"2026-04-24","ACTUAL",{"date":121,"type":119},"2024-02-05",{"date":123,"type":100},"2028-09-01",{"name":5,"class":6},1]