OncoMatch/Clinical Trials/NCT03926338
Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer
Is NCT03926338 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for colorectal cancer.
Treatment: Neoadjuvant toripalimab plus celecoxib for 6 cycles · Neoadjuvant toripalimab monotherapy for 6 cycles · Neoadjuvant toripalimab plus celecoxib for 12 cycles · Neoadjuvant toripalimab monotherapy for 12 cycles · Toripalimab plus celecoxib as neoadjuvant or definitive therapy — Colorectal cancer of Mismatch Repair-deficient (dMMR)/ Microsatellite Instability-high (MSI-H) accounts for approximately 15% of all colorectal cancer patients, with a higher proportion in right colon cancer. Previous studies have found that colon cancer patients with dMMR/MSI-H cannot benefit from 5-fluorouracil (5-FU) adjuvant chemotherapy. Once patients have distant metastases, they are not sensitive to traditional palliative chemotherapy, and the prognosis is significantly worse than that of mismatch repair-proficient (pMMR)/microsatellite stability (MSS). A phase II clinical study of anti-PD-1 immunotherapy based on mismatch repair (MMR) status published in 《N Engl J Med》 showed that the objective response rate (ORR) of advanced colorectal cancer patients with dMMR received anti-PD-1 is 40%, and a longer response time can be obtained compared to conventional chemotherapy. Anti-PD-1 neoadjuvant therapy has proven to be safe and feasible in lung cancer, bladder cancer and malignant melanoma, and can achieve more than 40% of major pathological response. However, there are no reports of anti-PD-1 neoadjuvant therapy for the dMMR/MSI-H colorectal cancer. Therefore, the aim of this study was to find the best multidisciplinary treatment for resectable colorectal cancer patient with the dMMR/MSI-H phenotype and to explore whether cyclooxygenase (COX) inhibitors combined with anti-PD-1 monoclonal antibody (mAb) could further improve efficacy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Disease stage
Required: Stage CN1, CN2
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic anticancer therapy
No previous any systemic anticancer therapy for colorectal cancer disease
Cannot have received: anti-PD-1 therapy
Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT03926338 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.
What disease stage is eligible?
Stage CN1 or CN2 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.
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