Neoadjuvant CAPEOX Versus Upfront Surgery for Locally Advanced Colon Cancer With Elevated CEA: A Single-Center, Open-Label, Randomized Controlled Trial

Starting soon · Not applicable

Conditions studied: Minimal Residual Disease, Immunoscore, Neoadjuvant Chemotherapy, Colon Cancer (Stage II &Amp; III)

In brief

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/mL) 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: * Does a treatment strategy involving neoadjuvant CAPOX followed by surgery improve 2y-DFS compared with upfront surgery followed by standard adjuvant chemotherapy? * Do postoperative ctDNA-MRD status and its longitudinal dynamics predict 2y-DFS? * Does combining ctDNA-MRD with Immunoscore enhance prognostic risk stratification for recurrence beyond either biomarker alone? Participants will: * Be randomized 1:1 (N=100) to one of two treatment pathways: * Arm A: Neoadjuvant CAPOX × 4 cycles → curative surgery (R0 planned) → postoperative management per standard practice * Arm B: Upfront curative surgery → postoperative standard adjuvant chemotherapy per guideline → routine surveillance * 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. * Provide postoperative blood samples for ctDNA-MRD testing at approximately postoperative day \~7 and day \~30 (before adjuvant therapy start, if applicable). * During follow-up, provide serial blood samples every 3 months, aligned with routine surveillance visits, for repeat ctDNA-MRD analysis. * Receive standard-of-care postoperative surveillance (including imaging and clinical evaluations) through 2 years, with all study-mandated assessments covered by the trial. This 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.

Key facts

Study ID

NCT07413146

Run by

Sun Yat-sen University

People needed

100

Starts

2026-02-24

Expected to finish

2027-07-31

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet all of the following criteria:
• Age 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.
• Histologically or cytologically confirmed colon adenocarcinoma, non-MSI-H/dMMR, with pathologic stage (AJCC/UICC TNM 8th edition) of:
• High-risk stage II, or Stage III. High-risk stage II features include: T4, poor/undifferentiated histology (high grade; excluding MSI-H), lymphovascular invasion, perineural invasion, preoperative bowel obstruction or tumor perforation, positive/unknown margin status, insufficient margin clearance, <12 lymph nodes examined, or high-grade tumor budding.
• Tumor location consistent with colon cancer: distal tumor margin ≥12 cm from the anal verge on preoperative endoscopy.
• Baseline serum CEA >5 ng/mL prior to treatment. No evidence of distant metastasis (distant organ and/or distant lymph node metastasis) based on comprehensive clinical evaluation.
• Ability to provide required clinical data for study collection. Ability to provide adequate fresh tumor tissue from endoscopy and/or surgery for WES/NGS to develop an individualized ctDNA MRD panel, and ability to provide required blood samples for ctDNA testing (baseline, postoperative \~day 7, postoperative \~day 30).
• Candidate 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.

You may not qualify if…

• Participants will be excluded if any of the following apply:
• Prior or concurrent other malignant tumor. Any severe comorbidity that, in the investigator's judgment, may significantly affect follow-up or short-term survival.
• Any other medical condition, or social/psychological circumstance, that in the investigator's judgment makes the participant unsuitable for the study.
• MSI-H/dMMR tumor. Evidence of metastatic disease by pathology, clinical assessment, or imaging, including isolated distant lesions, distant disease, or non-contiguous intraperitoneal metastasis.
• Multiple 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/NGS or personalized MRD panel development, personalized MRD panel customization failure, or unable to provide required blood samples (baseline, postoperative \~day 7, postoperative \~day 30).
• History of blood transfusion within 2 weeks prior to surgery or intraoperatively.
• Unable 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/bacterial/viral infection requiring systemic therapy.
• Inadequate bone marrow reserve or organ function meeting any of the following laboratory abnormalities (within 1 week prior to testing without corrective treatment):
• ANC < 1.5 × 10⁹/L Platelets < 90 × 10⁹/L Hemoglobin < 90 g/L (<9 g/dL) ALT > 3 × ULN AST > 3 × ULN or total bilirubin > 1.5 × ULN Creatinine > 1.5 × ULN or creatinine clearance < 45 mL/min (Cockcroft-Gault) Albumin < 28 g/L 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.

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