OncoMatch/Clinical Trials/NCT06368141
Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer
Is NCT06368141 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Serplulimab and Capecitabine for colon cancer.
Treatment: Serplulimab · Capecitabine · Oxaliplatin — The goal of this clinical trial is to learn the effect of neoadjuvant chemotherapy plus sequential immune checkpoint inhibitor (ICI) therapy in locally advanced colon cancer. The main questions it aims to answer are: * Does this neoadjuvant chemotherapy increase the pathologic complete response (pCR) of locally advanced colon cancer? * Does this neoadjuvant chemotherapy improve the long-term survival of locally advanced colon cancer? Participants will receive: * a pre-operative CAPEOX (capecitabine oral + oxaliplatin i.v.)regimen. * a sequential CAPEOX plus Serplulimab regimen. * a standard complete mesocolic excision (CME) operation.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR microsatellite stable
MSS/RAS mutation patients
Required: KRAS mutation
MSS/RAS mutation patients
Required: NRAS mutation
MSS/RAS mutation patients
Disease stage
Required: Stage T3N1-2, T4N0-2
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Cannot have received: surgery
Cannot have received: chemotherapy
Cannot have received: immunotherapy
Cannot have received: molecular targeted therapy
Cannot have received: other clinical research drugs
Cannot have received: immune checkpoint inhibitor
Lab requirements
Blood counts
Absolute value of neutrophils ≥ 1.5 × 10^9/L, platelet ≥ 100 × 10^9/L, hemoglobin concentration ≥ 9g/dL
Kidney function
serum creatinine ≤ 1.5 × ULN, or creatinine clearance rate (CCr) ≥ 60ml/min
Liver function
bilirubin ≤ 1.5 × ULN; aspartate transaminase and glutamate transaminase ≤ 2.5 × ULN; if there is liver metastasis, AST and ALT ≤ 5 × ULN
Cardiac function
Left ventricular ejection fraction <50% detected by echocardiography excluded; III-IV cardiac insufficiency according to NYHA standard excluded
Sufficient organ and bone marrow function confirmed by laboratory examinations within 7 days prior to the first use of the study medication, without severe hematopoietic abnormalities, heart, lung, liver, kidney dysfunction, and immune deficiency
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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