[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628975":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":35,"locations":41,"responsibleParty":57,"collaborators":59,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":34,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":44,"whyStopped":34,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"1.Monoclonal Antibody 2. Immunotherapy 3. Chemotherapy","EXPERIMENTAL","1. Tolecizumab (PCSK9 inhibitor) 600mg, subcutaneous injection, Q6W (Weeks 1,7), total 2 doses\n2. Sintilimab (PD-1 inhibitor) 200mg, intravenous infusion, Q3W (Weeks1,4,7,10), total 4 cycles\n3. CapeOX regimen (Oxaliplatin + Capecitabine) Oxaliplatin 130mg\u002Fm², IV infusion Q3W (4 cycles); Capecitabine 1000mg\u002Fm², oral twice daily, Days1-14 per cycle",[13,14],"Drug: Tolecizumab (PCSK9 Inhibitor)","Drug: Sintilimab",{"label":16,"type":10,"description":17,"interventionNames":18},"1. Immunotherapy 2. Chemotherapy","1. Sintilimab (PD-1 inhibitor) 200mg, intravenous infusion, Q3W (Weeks1,4,7,10), total 4\n2. CapeOX regimen (Oxaliplatin + Capecitabine) Oxaliplatin 130mg\u002Fm², IV infusion Q3W (4 cycles); Capecitabine 1000mg\u002Fm², oral twice daily, Days1-14 per cycle",[14],[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Tolecizumab (PCSK9 Inhibitor)","Tolecizumab (PCSK9 Inhibitor) 600mg, subcutaneous injection, Q6W (Weeks 1,7), 2 doses total Sintilimab (PD-1 Inhibitor) 200mg, intravenous infusion, Q3W (Weeks1,4,7,10), 4 cycles total CapeOX Regimen (Oxaliplatin + Capecitabine) Oxaliplatin 130mg\u002Fm² IV Q3W (4 cycles); Capecitabine 1000mg\u002Fm² oral twice daily, Days1-14 per cycle",[9],[26,27],"Sintilimab (PD-1 Inhibitor)","CapeOX Regimen (Oxaliplatin + Capecitabine)",{"type":21,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sintilimab","1. Oxaliplatin: 130mg\u002Fm² intravenous infusion, Q3W at Week 1,4,7,10, total 4 cycles; 2. Capecitabine: 1000mg\u002Fm² oral administration, twice daily, Days 1-14 of each chemotherapy cycle. All drugs free of charge.\n2. Sintilimab 200mg intravenous infusion, administered every 3 weeks (Q3W) at Week 1, 4, 7, 10, total 4 cycles; provided free of charge by the sponsor, used for neoadjuvant immunotherapy.",[16,9],[33],"CapeOX",null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"fan Li, PhD","CONTACT","86-18696539200","levinecq@163.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":34,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Daping Hospital Third Military Medical University, chongqing, chongqing 400000 Recruiting","RECRUITING","Chongqing","Chongqing Municipality","China","CN",{"type":50,"coordinates":51},"Point",[52,53],106.55771,29.56026,{"lat":53,"lon":52},[56],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},{"type":58,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[60,62],{"name":61,"class":6},"Southwest Hospital, China",{"name":63,"class":64},"Chongqing Shapingba District People's Hospital","UNKNOWN","100628975","phase-2-tolecizumab-plus-chemoimmunotherapy-for-pmmrmss-locally-advanced-colon-adenocarcinoma-100628975",false,"NCT07468630","Tolecizumab Plus Chemoimmunotherapy for pMMR\u002FMSS Locally Advanced Colon Adenocarcinoma","A Multicenter, Randomized, Open-Label, Blinded-Endpoint Phase II Study of Tolecizumab (a PCSK9 Inhibitor) Enhancing Chemoimmunotherapy as Neoadjuvant Treatment for Patients With pMMR\u002FMSS Locally Advanced Colon Adenocarcinoma (TRIUNITE-08)","TRIUNITE-08","Inclusion Criteria:\n\n* Signed the written informed consent form and voluntarily participate in the study.\n\nPathohistologically confirmed colon adenocarcinoma with cT3c stage or above. Aged 18 to 80 years, regardless of gender. The lower edge of the tumor is more than 10 cm from the anus. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Sufficient bone marrow, liver, kidney and coagulation functions assessed by laboratory tests (in accordance with the local laboratory reference range).\n\nNo previous anti-tumor treatment for the current colon cancer (including radiotherapy, chemotherapy, surgery, etc.).\n\nNo pregnancy or lactation for female patients; male patients agree to take effective contraceptive measures during the study.\n\nExclusion Criteria:\n\n* Previous anti-tumor treatment for the current colon cancer. Previous use of PCSK9 inhibitors or PD-1\u002FPD-L1 inhibitors. Active autoimmune diseases or a history of autoimmune diseases. Receiving immunosuppressant or systemic glucocorticoid therapy (except for local low-dose glucocorticoid use).\n\nActive infection requiring systemic anti-infective treatment. Severe cardiovascular diseases (e.g., severe hypertension, myocardial infarction, heart failure, etc.).\n\nComplicated primary tumor (e.g., tumor perforation, intestinal obstruction without relief after intervention).\n\nPregnant or lactating women. Other conditions that the investigator deems unfit for participation in the study (e.g., poor compliance, severe organ dysfunction, etc.).","ALL","18 Years","80 Years",{"count":77,"type":78},106,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","This multicenter, randomized, open-label, blinded-endpoint Phase II trial assesses the efficacy and safety of tolecizumab (PCSK9 inhibitor) plus sintilimab\u002FCapeOX chemoimmunotherapy as neoadjuvant treatment for pMMR\u002FMSS locally advanced colon adenocarcinoma (cT3c+). 106 patients are 1:1 randomized to the combination or chemoimmunotherapy alone, with pCR as the primary endpoint.",[84],"Colon Adenocarcinoma",[86,87,88,89],"pMMR\u002FMSS","neoadjuvant immunochemotherapy","PCSK9 inhibitor","Tolecizumab","2026-03-09",{"date":92,"type":93},"2026-03-12","ACTUAL",{"date":95,"type":78},"2026-04-10",{"date":97,"type":78},"2028-12-31",{"name":5,"class":6},1]