[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535645":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":20,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"First Affiliated Hospital of Guangxi Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"neoadjuvant Tislelizumab combined with chemotherapy","EXPERIMENTAL","Patients with locally advanced rectal cancer who met the inclusion criteria received two or four cycles of Tislelizumab combined Capecitabine and Oxaliplatin regimen chemotherapy and were evaluated by enhanced CT and MRI\\\\TRUS. Then, these patients will receive curative surgery for rectal cancer.\n\nInterventions:\n\nDrug: Oxaliplatin Drug: Capecitabine Drug: Tislelizumab Procedure: curative surgery for rectal cancer",[13],"Drug: Tislelizumab combined with chemotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Tislelizumab combined with chemotherapy","Drug: Oxaliplatin Oxaliplatin 130mg\u002Fm2 for chemotherapy 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 report in BJC (2018) 118:1322-1328.\n\nDrug: 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 report in BJC (2018) 118:1322-1328.\n\nDrug: Anti-PD-1 Monoclonal Antibody 200 mg on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The incidence of adverse events with Anti-PD-1 Monoclonal Antibodies is relatively low. The PD-1 monoclonal antibody (Tislelizumab) dose adjustment was implemented according to the prescribing information.\n\nOther Names:\n\nTislelizumab\n\nProcedure: Colectomy The specific surgical approach, whether it be laparoscopic",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Hui Li, Professor","STUDY_CHAIR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Sen Zhang, Professor","CONTACT","13407738560","zs0771@126.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"The First Affiliated Hospital of Guangxi Medical University","RECRUITING","Nanning","Guangxi","530021","China","CN",{"type":41,"coordinates":42},"Point",[43,44],108.31667,22.81667,{"lat":44,"lon":43},[47],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Hui Li","Deputy chief physician","100535645","phase-2-the-effects-of-neoadjuvant-tislelizumab-combined-with-chemotherapy-in-locally-advanced-mss-rectal-cancer-100535645",false,"NCT06254521","The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer","Neoadjuvant Treatment of Locally Advanced MSS Rectal Cancer With Tislelizumab Combined With CAPOX Regimen: a Prospective, Single-arm, Single-center, Exploratory Phase II Clinical Study","Inclusion Criteria:\n\n* Age ≥18 years old and ≤70 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 less than 12cm from the anus as measured by colonoscopy and MRI,or TRUS.\n* It was confirmed by magnetic resonance imaging (MRI) or intracavitary ultrasound of the rectum as T3-4 or N+, and M0 by enhanced CT.\n* The ECOG 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 ≥ 90g\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* Early rectal cancer (T1-2N0M0); The lower margin of the tumor was less than 5cm from the anus and T4. APR(combined abdominal perineal resection) is required;\n* Multifocal colorectal cancer.\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 COPD, coronary heart disease, and renal insufficiency) and\u002For severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), ASA 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",{"count":62,"type":63},60,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced MSS rectal cancer.",[69,70,71],"Rectal Cancer","Rectal Cancer Stage II","Rectal Cancer Stage III",[73,74,75],"locally advanced rectal cancer","neoadjuvant","PD-1","2024-02-03",{"date":78,"type":79},"2024-02-12","ACTUAL",{"date":81,"type":63},"2024-02-22",{"date":83,"type":63},"2027-12-30",{"name":5,"class":6},1]