New Protocol: Neoadjuvant Toripalimab with Celecoxib for MSI-H Colorectal Cancer

This randomized phase 2 study investigated the efficacy of neoadjuvant toripalimab plus celecoxib compared to toripalimab monotherapy in patients with dMMR or MSI-H locally advanced colorectal cancer. The combination therapy significantly increased the pathological complete response rate. The safety profiles were similar between the two groups, supporting further investigation of this combination in larger trials.

  • Study

    Randomised, open-label, multicentre, phase 2 trial [PICC-2, NCT03926338]
    dMMR or MSI-H, locally advanced colorectal cancer
    Neoadjuvant toripalimab plus celecoxib (n=55) vs toripalimab monotherapy (n=55)



  • Efficacy

    pCR: 89% vs 69% (celecoxib + toripalimab vs. toripalimab alone)



  • Safety

    Grade >=3 AE: tumour perforation (4% vs 2%), bowel obstruction (2% vs 0%), rash (0% vs 2%), increased aminotransferase (0% vs 2%), hypothyroidism (0% vs 2%)
    Serious treatment-related adverse events: 7% vs 7%
    Treatment-related AE leading to discontinuation: 7% vs 5%


  • Lancet Oncol. Published online July 1, 2026

    Hu H, Shen X, Li Y Neoadjuvant toripalimab plus celecoxib versus toripalimab monotherapy for mismatch repair-deficient or microsatellite instability-high, locally advanced colorectal cancer (PICC-2): an open-label, multicentre, randomised, phase 2 trial

    http://doi.org/10.1016/S1470-2045(26)00220-2

    Reviewed by Ulas D. Bayraktar, MD on Aug 13, 2026

    Back to top Drag