OncoMatch/Clinical Trials/NCT06903858
Neoadjuvant Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer
Is NCT06903858 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Toripalimab combined with celecoxib for colorectal cancer (crc).
Treatment: Toripalimab combined with celecoxib — Several Phase II studies have demonstrated the feasibility, effectiveness, and good tolerability of neoadjuvant immune checkpoint inhibitor (ICI) treatment for localized dMMR colorectal and rectal cancers. The significant clinical and pathological complete response rates offer the possibility of avoiding surgical resection. dMMR colorectal cancers are generally larger and more advanced than pMMR tumors, often requiring more extensive surgery with associated risks such as anastomotic leakage, ureteral injury, and infection. If oncological outcomes are not affected (requiring long-term follow-up), non-surgical treatment becomes an attractive option for localized dMMR colorectal cancer. Moreover, pelvic radiotherapy, the standard for locally advanced rectal cancer, causes both short-term and long-term adverse effects (e.g., bowel and bladder dysfunction, fistula, infertility), significantly impacting quality of life. Total mesorectal excision also carries risks of complications and sexual dysfunction, often requiring a stoma, making organ preservation a more urgent need for rectal cancer patients. Phase II trials and the international "watch-and-wait" database have confirmed the feasibility and safety of organ preservation for pMMR locally advanced rectal cancer. Therefore, the high clinical and pathological complete response rates achieved by neoadjuvant immunotherapy for dMMR/MSI-H rectal cancer offer promising prospects for non-surgical treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR deficient mismatch repair
dMMR (IHC)
Required: MSI microsatellite instability-high
MSI-H (PCR)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Prior treatment with anti-PD-1/PD-L1 antibodies
Cannot have received: anti-PD-L1 therapy
Prior treatment with anti-PD-1/PD-L1 antibodies
Cannot have received: anti-CTLA-4 therapy
Prior treatment with anti-CTLA-4 antibodies
Cannot have received: checkpoint inhibitor
other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways
Cannot have received: systemic chemotherapy
No prior anti-cancer therapy for colonrectal cancer (surgery/chemotherapy/targeted therapy/radiation)
Cannot have received: targeted therapy
No prior anti-cancer therapy for colonrectal cancer (surgery/chemotherapy/targeted therapy/radiation)
Cannot have received: radiation therapy
No prior anti-cancer therapy for colonrectal cancer (surgery/chemotherapy/targeted therapy/radiation)
Cannot have received: surgery
No prior anti-cancer therapy for colonrectal cancer (surgery/chemotherapy/targeted therapy/radiation)
Lab requirements
Blood counts
Kidney function
Liver function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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