OncoMatch/Clinical Trials/NCT05731726
Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer
Is NCT05731726 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Serplulimab and Capecitabine for pmmr.
Treatment: Serplulimab · Capecitabine · Oxaliplatin · Celecoxib — Colorectal cancer of Mismatch Repair-proficient (pMMR)/ Microsatellite Stability (MSS) accounts for approximately 85% of all colorectal cancer patients, which might be insensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy, such as CAPEOX regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Celecoxib, a COX-2 inhibitor, can improve the immune microenvironment and have a potential to synergy with immunotherapy. Chemotherapy can improve the immunogenicity of cancer cells that might enhance the efficacy of immunotherapy. The aim of this study is to explore whether chemotherapy and cyclooxygenase (COX) inhibitors combined with anti-PD-1 monoclonal antibody (mAb) could improve efficacy for resectable colorectal cancer patient with the pMMR/MSS phenotype.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR proficient
pMMR; MSS; MSI-L
Required: MSI microsatellite stable
pMMR; MSS; MSI-L
Required: MSI microsatellite instability-low
pMMR; MSS; MSI-L
Disease stage
Required: Stage CT2N1-2M0, CT3N0-2M0, CT4N0-2M0 (clinical TNM)
cT2N1-2M0, cT3N0-2M0, cT4N0-2M0 MSS with MRF(-) assessed by MRI.
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic anticancer therapy
No previous any systemic anticancer therapy for rectal cancer disease.
Cannot have received: immune checkpoint inhibitor
previously been treated with other antibodies/drugs that target immune checkpoints, such as PD-1, PD-L1, and cytotoxic T lymphocyte-associated Antigen 4 (CTLA-4).
Lab requirements
Liver function
AST ≤ 3 x ULN; if HCV-RNA positive, both ALT and AST ≤ 3 x ULN
Cardiac function
No history of myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms in women), NYHA Grade III-IV cardiac insufficiency, LVEF <50%
Aspartate aminotransferase (AST) must be ≤ 3 x ULN for the lab. If HCV-RNA is positive, patients with both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) performed ≤3×ULN could be enrolled. History of myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms in women) in the 6 months prior to enrollment (QTc interval calculated by Fridericia formula). According to New York College of Cardiology (NYHA) standards for Grade III-IV cardiac insufficiency or cardiac color ultrasound: left ventricular ejection fraction (LVEF) <50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05731726 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require MMR?
Yes, MMR proficient is a required biomarker for enrollment.
Does this trial require MSI?
Yes, MSI microsatellite stable is a required biomarker for enrollment.
Does this trial require MSI?
Yes, MSI microsatellite instability-low is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT2N1-2M0 or CT3N0-2M0 or CT4N0-2M0 is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages