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.
None
None
Parallel
ctDNA-Based Molecular Residual Disease (MRD) Monitoring and Immunoscore Assessment
Diagnostic testThis study uses personalized circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) monitoring together with tumor immune profiling (Immunoscore) for postoperative risk stratification. At baseline, primary tumor tissue obtained by endoscopy and/or surgery undergoes next-generation sequencing/whole-exome sequencing to identify patient-specific somatic variants and to build an individualized ctDNA MRD assay panel. Peripheral blood is collected at baseline, approximately postoperative day 7, postoperative day 30 (before adjuvant therapy when feasible), and every 3 months during routine follow-up for serial MRD testing (MRD positive/negative and longitudinal changes). Immunoscore is assessed from resected tumor tissue using a standardized, validated workflow to quantify intratumoral and invasive-margin immune cell densities and is categorized per assay reporting. MRD status and Immunoscore are integrated to define biomarker-based recurrence risk groups and correlated with cli
Neoadjuvant Chemotherapy
DrugIn ARM A, patient receive neoadjuvant CAPEOX chemotherapy for 4 cycles before surgery.
Adjuvant chemotherapy
DrugThe application of post-operative adjuvant chemotherapy depends on the final pathological staging, under the guidance of the NCCN/ESMO/CSCO guidelines for colorectal cancer.
2-year Disease-Free Survival (2y-DFS)
Disease-free survival is defined as the time from curative-intent surgery to the first occurrence of any of the following events: (1) local recurrence, (2) distant metastasis, (3) a second primary colorectal cancer, or (4) death from any cause, whichever occurs first. Participants without an event will be censored at the last disease assessment.
2-year Overall Survival (2y-OS)
Overall survival is defined as the time from curative-intent surgery to death from any cause. Participants alive at the end of follow-up will be censored at the last known date alive.
Local Recurrence Rate at 2 years
Proportion of participants who develop local recurrence (tumor recurrence at or adjacent to the primary tumor bed/anastomosis and/or regional sites consistent with local-regional relapse, as determined by standard clinical assessment and imaging/pathology when available) within 24 months after surgery.
Distant Metastasis Rate at 2 years
Proportion of participants who develop distant metastasis (metastatic disease in distant organs and/or distant lymph nodes, confirmed by standard imaging and/or pathology per routine clinical practice) within 24 months after surgery.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
