[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603091":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":45,"locations":55,"responsibleParty":68,"collaborators":70,"id":75,"slug":50,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":50,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":50,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":99,"whyStopped":50,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"First Affiliated Hospital of Guangxi Medical University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"CAPOX combined with Tislelizumab","EXPERIMENTAL","Patients in the experimental group underwent two or four cycles of preoperative CAPOX combined with Tislelizumab. Patients assessed as suitable for R0 resection by imaging underwent radical colectomy. Following surgery, all patients in both groups completed an additional four or six cycles of adjuvant CAPOX chemotherapy.",[13,14,15],"Drug: Tislelizumab","Drug: Oxaliplatin","Drug: Capecitabine",{"label":17,"type":18,"description":19,"interventionNames":20},"CAPOX chemotherapy","PLACEBO_COMPARATOR","Patients in the experimental group underwent two or four cycles of preoperative CAPOX combined with placebo. Patients assessed as suitable for R0 resection by imaging underwent radical colectomy. Following surgery, all patients in both groups completed an additional four or six cycles of adjuvant CAPOX chemotherapy.",[14,15],[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Tislelizumab","200 mg on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The incidence of adverse events with Tislelizumab is relatively low. The Tislelizumab dose adjustment was implemented according to the prescribing information.",[9],[28],"Baizean",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Oxaliplatin","Oxaliplatin 130mg\u002Fm2 on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The dose reduction protocol for oxaliplatin-induced toxicity was implemented according to the study in British Journal of Cancer (2018) 118:1322-1328.",[17,9],[34],"Eloxatin",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Capecitabine","Oral Capecitabine 1000 mg\u002Fm2 twice daily combined with oxaliplatin chemotherapy from Day 1 to Day 14 every 3 weeks and repeat for 2 or 4 cycles. The dose reduction protocol for capecitabine-induced toxicity was implemented according to the study in British Journal of Cancer (2018) 118:1322-1328.",[17,9],[40],"Xeloda",[42],{"name":43,"affiliation":5,"role":44},"Sen Zhang","STUDY_DIRECTOR",[46,52],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Minglin Lin","CONTACT","+86-771-5356529",null,"linminglin@sr.gxmu.edu.cn",{"name":53,"role":48,"phone":49,"phoneExt":50,"email":54},"Ming Qiu","1347521825@qq.com",[56],{"facility":57,"status":50,"city":58,"state":59,"zip":60,"country":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":50},"The First Affiliated Hospital of Guangxi Medical University","Nanning","Guangxi","530021","China",{"type":63,"coordinates":64},"Point",[65,66],108.31667,22.81667,{"lat":66,"lon":65},{"type":69,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR",[71,73],{"name":72,"class":6},"The First Affiliated Hospital of Xiamen University",{"name":74,"class":6},"The First Affiliated Hospital of University of South China","100603091",false,"NCT07132008","Neoadjuvant CAPOX Plus Tislelizumab vs CAPOX in MSS High-Risk Locally Advanced Colon Cancer","Prospective, Multicenter, Randomized Trial of Neoadjuvant Capecitabine and Oxaliplatin (CAPOX) Plus Tislelizumab Versus CAPOX in Microsatellite Stable High-risk Locally Advanced Colon Cancer","Inclusion Criteria:\n\n* Age ≥18 years old and ≤75 years old.\n* Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by immunohistochemistry)) colon adenocarcinoma.\n* The lower edge of the tumor is more than 12cm from the anus as measured by colonoscopy and the lower edge of the tumor cannot be directly palpated during rectal examination.\n* Enhanced CT stage T4 or T1-4 N+ without multiple primary tumors or distant metastasis.\n* The Eastern Cooperative Oncology Group physical status score is 0-1.\n* Life expectancy is expected to be more than 1 year.\n* First diagnosis, no previous anti-tumor treatment received, and no chemotherapy contraindications.\n* Appropriate organ function is defined as follows: Hemoglobin level ≥ 60g\u002FL, Neutrophil count ≥ 1.5×10\\^9\u002FL, Platelet count ≥ 75×10\\^9\u002FL, Serum total bilirubin ≤ 1.5× the upper limit of normal (UNL), Aspartate aminotransferase (AST) ≤ 2× UNL, Alanine aminotransferase (ALT) ≤ 3× UNL, Serum creatinine ≤ 1.5× UNL.\n* Informed consent, able to understand the study protocol and willing to participate in the study, and will provide written informed consent.\n\nExclusion Criteria:\n\n* Enhanced CT stage (T1-3N0M0)\n* Multifocal colorectal cancer.\n* CT or MRI in the mid-sagittal plane shows that the lower border of the tumor is below the line connecting the sacrococcygeal promontory and the upper border of the pubic symphysis.\n* Tumor obstruction or high risk of obstruction, bleeding, and\u002For perforation requiring emergency surgery or stent placement.\n* Cannot tolerate chemotherapy or immunotherapy, such as but not limited to bone marrow suppression.\n* History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers.\n* Acute exacerbation of important organ diseases (such as but not limited to chronic obstructive pulmonary disease, coronary heart disease, and renal insufficiency) and\u002For severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), American Society of Anesthesiologists score \\> 3 points.\n* Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol.\n* Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy.\n* Continuous use of glucocorticoids for more than 3 days within 1 month prior to signing the informed consent form, or having comorbidities requiring the use of glucocorticoid therapy.\n* Unable to undergo enhanced CT examination\n* Pregnancy or lactation.\n* Refused to participate in this study.\n* Other situations in which the researcher deems unsuitable for this study.","ALL","18 Years","75 Years",{"count":85,"type":86},94,"ESTIMATED","INTERVENTIONAL",[89],"PHASE3","Building on earlier exploratory work, this study further designs a multi-institutional, prospective, randomized clinical trial to evaluate the efficacy and safety of the combination therapy of the immune checkpoint inhibitor Tislelizumab with CAPOX for neoadjuvant treatment in high-risk locally advanced MSS-type colorectal cancer, as well as its impact on patient outcomes. This study aims to provide new evidence for the clinical practice of treating MSS-type colorectal cancer.",[92,93,94],"Colonic Neoplasms","Neoadjuvant Therapy","Immune Checkpoint Inhibitors",[96,97,98],"Colon cancer","Neoadjuvant chemotherapy","PD-1 inhibitor","NOT_YET_RECRUITING","2025-08-13",{"date":102,"type":103},"2025-08-20","ACTUAL",{"date":105,"type":86},"2025-10-01",{"date":107,"type":86},"2030-09-30",{"name":5,"class":6},1]