Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer

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

Trial Details

NCT ID
NCT03926338
Phase
PHASE2
Sponsor
Sun Yat-sen University
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • 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
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Willing and able to provide written informed consent.
  • Histological or cytological documentation of adenocarcinoma of the colon or rectum.
  • Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) b…
  • Male or female subjects aged 18 to 75 years.

For full eligibility, visit ClinicalTrials.gov.

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