[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immunoscore\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immunoscore":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100624708","neoadjuvant-capeox-versus-upfront-surgery-for-locally-advanced-colon-cancer-with-elevated-cea-a-single-center-open-label-randomized-controlled-trial-100624708",false,"NCT07413146","Neoadjuvant CAPEOX Versus Upfront Surgery for Locally Advanced Colon Cancer With Elevated CEA: A Single-Center, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\nAge 18 to 70 years (inclusive) at the time of written informed consent. ECOG performance status 0-1, without deterioration within 2 weeks prior to enrollment; anticipated life expectancy ≥12 weeks.\n\nHistologically or cytologically confirmed colon adenocarcinoma, non-MSI-H\u002FdMMR, with pathologic stage (AJCC\u002FUICC TNM 8th edition) of:\n\nHigh-risk stage II, or Stage III. High-risk stage II features include: T4, poor\u002Fundifferentiated histology (high grade; excluding MSI-H), lymphovascular invasion, perineural invasion, preoperative bowel obstruction or tumor perforation, positive\u002Funknown margin status, insufficient margin clearance, \\\u003C12 lymph nodes examined, or high-grade tumor budding.\n\nTumor location consistent with colon cancer: distal tumor margin ≥12 cm from the anal verge on preoperative endoscopy.\n\nBaseline serum CEA \\>5 ng\u002FmL prior to treatment. No evidence of distant metastasis (distant organ and\u002For distant lymph node metastasis) based on comprehensive clinical evaluation.\n\nAbility to provide required clinical data for study collection. Ability to provide adequate fresh tumor tissue from endoscopy and\u002For surgery for WES\u002FNGS to develop an individualized ctDNA MRD panel, and ability to provide required blood samples for ctDNA testing (baseline, postoperative \\~day 7, postoperative \\~day 30).\n\nCandidate for curative-intent R0 resection. Willing and able to comply with the protocol schedule, including regular follow-up visits and necessary treatments, and provides written informed consent.\n\nExclusion Criteria:\n\nParticipants will be excluded if any of the following apply:\n\nPrior or concurrent other malignant tumor. Any severe comorbidity that, in the investigator's judgment, may significantly affect follow-up or short-term survival.\n\nAny other medical condition, or social\u002Fpsychological circumstance, that in the investigator's judgment makes the participant unsuitable for the study.\n\nMSI-H\u002FdMMR tumor. Evidence of metastatic disease by pathology, clinical assessment, or imaging, including isolated distant lesions, distant disease, or non-contiguous intraperitoneal metastasis.\n\nMultiple primary colon cancers. Underwent open surgery at a non-colon site within 14 days prior to enrollment. Unable to provide required tumor tissue for WES\u002FNGS or personalized MRD panel development, personalized MRD panel customization failure, or unable to provide required blood samples (baseline, postoperative \\~day 7, postoperative \\~day 30).\n\nHistory of blood transfusion within 2 weeks prior to surgery or intraoperatively.\n\nUnable to undergo contrast-enhanced CT or MRI for routine clinical follow-up. Fever ≥38°C within the past 7 days, or clinically significant active infection (including active tuberculosis), or active fungal\u002Fbacterial\u002Fviral infection requiring systemic therapy.\n\nInadequate bone marrow reserve or organ function meeting any of the following laboratory abnormalities (within 1 week prior to testing without corrective treatment):\n\nANC \\\u003C 1.5 × 10⁹\u002FL Platelets \\\u003C 90 × 10⁹\u002FL Hemoglobin \\\u003C 90 g\u002FL (\\\u003C9 g\u002FdL) ALT \\> 3 × ULN AST \\> 3 × ULN or total bilirubin \\> 1.5 × ULN Creatinine \\> 1.5 × ULN or creatinine clearance \\\u003C 45 mL\u002Fmin (Cockcroft-Gault) Albumin \\\u003C 28 g\u002FL Pregnant or breastfeeding, or planning pregnancy during the study period. Any other condition that, in the investigator's judgment, indicates the participant should not participate.","ALL","18 Years","70 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this interventional clinical trial is to compare the efficacy of neoadjuvant chemotherapy versus upfront surgery in adults aged 18-70 years with stage II (high-risk)-III, non-MSI-H colon adenocarcinoma and elevated baseline CEA (\\>5 ng\u002FmL) undergoing curative-intent treatment. This single-center, open-label, randomized controlled study will evaluate 2-year disease-free survival (2y-DFS) as the primary endpoint, with all study-related procedures-including longitudinal ctDNA-based molecular residual disease (MRD) monitoring, Immunoscore assessment, tumor tissue sequencing, and surveillance imaging-provided at no cost to participants. The main questions it aims to answer are:\n\n* Does a treatment strategy involving neoadjuvant CAPOX followed by surgery improve 2y-DFS compared with upfront surgery followed by standard adjuvant chemotherapy?\n* Do postoperative ctDNA-MRD status and its longitudinal dynamics predict 2y-DFS?\n* Does combining ctDNA-MRD with Immunoscore enhance prognostic risk stratification for recurrence beyond either biomarker alone?\n\nParticipants will:\n\n* Be randomized 1:1 (N=100) to one of two treatment pathways:\n\n  * Arm A: Neoadjuvant CAPOX × 4 cycles → curative surgery (R0 planned) → postoperative management per standard practice\n  * Arm B: Upfront curative surgery → postoperative standard adjuvant chemotherapy per guideline → routine surveillance\n* Undergo baseline assessments prior to treatment initiation, including blood draw, colonoscopy, primary tumor next-generation sequencing (for personalized ctDNA-MRD assay development), and Immunoscore testing-all provided free of charge as part of the study.\n* Provide postoperative blood samples for ctDNA-MRD testing at approximately postoperative day \\~7 and day \\~30 (before adjuvant therapy start, if applicable).\n* During follow-up, provide serial blood samples every 3 months, aligned with routine surveillance visits, for repeat ctDNA-MRD analysis.\n* Receive standard-of-care postoperative surveillance (including imaging and clinical evaluations) through 2 years, with all study-mandated assessments covered by the trial.\n\nThis trial integrates clinical intervention with comprehensive biomarker profiling to determine whether early systemic therapy alters MRD dynamics and improves outcomes in high-risk, CEA-elevated colon cancer.",[26,27,28,29],"Minimal Residual Disease","Immunoscore","Neoadjuvant Chemotherapy","Colon Cancer (Stage II &Amp; III)",[31,26,27,32,33],"advanced stage colon cancer","neoadjuvant chemotherapy","upfront surgery","NOT_YET_RECRUITING","2026-02-09",{"date":37,"type":38},"2026-02-17","ACTUAL",{"date":40,"type":20},"2026-02-24",{"date":42,"type":20},"2027-07-31",{"name":44,"class":45},"Sun Yat-sen University","OTHER"]