[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657749":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":46,"interventions":58,"overallOfficials":39,"centralContacts":68,"locations":74,"responsibleParty":91,"collaborators":93,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":39,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":39,"overallStatus":77,"whyStopped":39,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"pCR","pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes","The pCR rate will be evaluated after surgery, an average of 12 weeks",[14,18,22,25,29,33,37],{"measure":15,"description":16,"timeFrame":17},"MPR (Major Pathological Response)","MPR is defined as ≤10% residual viable tumor cells in the primary tumor bed of the surgical specimen following neoadjuvant therapy","MPR rate assessed postoperatively, at an average of 12 weeks",{"measure":19,"description":20,"timeFrame":21},"Disease-free survival","Defined as the time from randomization to relapse or death, whichever occurred first.","3 years",{"measure":23,"description":24,"timeFrame":21},"Overall survival (OS)","Defined as the time from randomization to date of death due to any cause according to RECIST version 1.1 recorded in the time period between randomization and disease",{"measure":26,"description":27,"timeFrame":28},"Primary tumor downstaging rate","Down-staging of the resected tumour as measured by histopathological tumour diameter and stage according to the TNM staging system of AJCC (9th version).","From enrollment to 12 Weeks of treatment end",{"measure":30,"description":31,"timeFrame":32},"R₀ （Curative） resection","Curative resection defined as complete tumor resection with all margins being negative.","Surgical operation assessment",{"measure":34,"description":35,"timeFrame":36},"Objective Response Rate (ORR)","Objective response is defined as a complete response (CR) or response (PR) according to RECIST v1.1","After 4 cycles of neoadjuvant therapy (10 weeks)",{"measure":38,"description":39,"timeFrame":28},"Radiological response based on RECIST 1.1 criteria: CR, PR, SD, PD",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE",[47,54],{"label":48,"type":49,"description":50,"interventionNames":51},"1.Tafolecimab 2. Immunotherapy 3. Chemotherapy","EXPERIMENTAL","Tafolecimab 600mg SC Q6W (Weeks 1, 7) + Sintilimab 200mg IV Q3W (Weeks 1, 4, 7, 10) + Oxaliplatin 130mg\u002Fm² IV Q3W (Weeks 1, 4, 7, 10) + Capecitabine 1000mg\u002Fm² PO BID Days 1-14 of each cycle, 4 cycles total. Arm B (Active Comparator): Sintilimab 200mg IV Q3W (Weeks 1, 4, 7, 10) + Oxaliplatin 130mg\u002Fm² IV Q3W (Weeks 1, 4, 7, 10) + Capecitabine 1000mg\u002Fm² PO BID Days 1-14 of each cycle, 4 cycles total.",[52,53],"Drug: Tafolecimab","Drug: Sintilimab",{"label":55,"type":49,"description":56,"interventionNames":57},"1. Immunotherapy 2. Chemotherapy","1\\. Sintilimab (PD-1 inhibitor) 200mg, intravenous infusion, Q3W (Weeks1,4,7,10), total 4 2. CapeOX regimen (Oxaliplatin + Capecitabine) Oxaliplatin 130mg\u002Fm², IV infusion Q3W (4 cycles); Capecitabine 1000mg\u002Fm², oral twice daily, Days1-14 per cycle",[53],[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":39},"DRUG","Tafolecimab","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",[48],{"type":60,"name":65,"description":66,"armGroupLabels":67,"otherNames":39},"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. 2.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.",[55,48],[69],{"name":70,"role":71,"phone":72,"phoneExt":39,"email":73},"fan Li, PhD","CONTACT","86-18696539200","levinecq@163.com",[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Daping Hospital Third Military Medical University","RECRUITING","Chongqing","Chongqing Municipality","400000","China","CN",{"type":84,"coordinates":85},"Point",[86,87],106.55771,29.56026,{"lat":87,"lon":86},[90],{"name":70,"role":71,"phone":72,"phoneExt":39,"email":73},{"type":92,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[94,97,99,102,104,106,108],{"name":95,"class":96},"Shapingba District People's Hospital","UNKNOWN",{"name":98,"class":6},"The Second Affiliated Hospital of Chongqing Medical University",{"name":100,"class":101},"Jiangbei Campus of The First Affiliated Hospital of Army Medical University (Army 958 Hospital)","OTHER_GOV",{"name":103,"class":96},"Third Affiliated Hospital of Chongqing Medical University",{"name":105,"class":96},"Chongqing Yongchuan District People's Hospital, Deyang People's Hospital",{"name":107,"class":96},"Guang'an People's Hospital, Kaizhou District People's Hospital",{"name":109,"class":6},"940 Hospital of the People's Liberation Army Joint Logistic Support Force","100657749","phase-2-tafolecimab-combined-with-chemoimmunotherapy-as-neoadjuvant-treatment-for-pmmrmss-locally-advanced-colon-cancer-100657749",false,"NCT07840677","Tafolecimab Combined With Chemoimmunotherapy as Neoadjuvant Treatment for pMMR\u002FMSS Locally Advanced Colon Cancer","A Multicenter, Randomized, Two-arm, Open-label, Blinded Endpoint, Phase II Study of PCSK9 Inhibitor Tafolecimab Combined With Sintilimab and CapeOX Chemotherapy as Neoadjuvant Treatment for pMMR\u002FMSS Locally Advanced Colon Cancer (TRIUNITE-08)","TRIUNITE-08","Inclusion Criteria:\n\n* Signed the written informed consent form and voluntarily participate in the study.\n* Pathohistologically confirmed colon adenocarcinoma with cT3c stage or above.\n* Aged 18 to 80 years, regardless of gender.\n* The lower edge of the tumor is more than 10 cm from the anus.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Sufficient bone marrow, liver, kidney and coagulation functions assessed by laboratory tests (in accordance with the local laboratory reference range).\n* No previous anti-tumor treatment for the current colon cancer (including radiotherapy, chemotherapy, surgery, etc.).\n* No 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.\n* Previous use of PCSK9 inhibitors or PD-1\u002FPD-L1 inhibitors.\n* Active autoimmune diseases or a history of autoimmune diseases.\n* Receiving immunosuppressant or systemic glucocorticoid therapy (except for local low-dose glucocorticoid use).\n* Active infection requiring systemic anti-infective treatment.\n* Severe cardiovascular diseases (e.g., severe hypertension, myocardial infarction, heart failure, etc.).\n* Fasting LDL-C \\\u003C1.0 mmol\u002FL (39 mg\u002FdL), only excluding extremely low levels (suggestive of cachexia\u002Fsevere hepatic disease)\n* Complicated primary tumor (e.g., tumor perforation, intestinal obstruction without relief after intervention).\n* Pregnant or lactating women.\n* 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":122,"type":123},70,"ESTIMATED","INTERVENTIONAL",[126],"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 .",[129,130,131],"Colon Cancer","PCSK9 Inhibitor","Neoadjuvant Immunochemotherapy","2026-09-19",{"date":134,"type":135},"2026-09-25","ACTUAL",{"date":137,"type":123},"2026-09-20",{"date":139,"type":123},"2029-09-20",{"name":5,"class":6},1]