Phase 2 Study of Serplulimab with CAPEOX and Celecoxib as Pre-Surgery Treatment for Locally Advanced Rectal Cancer

What this Trial Is About

Researchers are investigating a new treatment approach for patients with locally advanced rectal cancer that has a specific genetic profile called mismatch repair-proficient pMMR and microsatellite stable MSS. This type of colorectal cancer makes up about 85% of cases and may not respond well to immunotherapy alone. The study, sponsored by Zhejiang University, aims to see if combining chemotherapy and a COX-2 inhibitor with an anti-PD-1 monoclonal antibody can improve treatment outcomes in these patients. Participants will receive a combination of serplulimab, an anti-PD-1 monoclonal antibody, given every three weeks at a dose of 300 mg, alongside the CAPEOX chemotherapy regimen, which includes oxaliplatin 130 mgm2 intravenously on day 1 and capecitabine 1000 mgm2 taken orally twice daily from days 1 to 14. They will also take celecoxib, a COX-2 inhibitor, orally twice daily from days 1 to 21. This treatment cycle repeats every three weeks for 4 to 8 cycles, followed by surgery to remove the tumor. Throughout the study, participants will be closely monitored with imaging scans and laboratory tests to assess tumor response and immune markers. Researchers will evaluate the rate of complete pathological response one year after treatment, along with other outcomes like clinical response, safety, and disease-free survival over three years. The total participation time includes the treatment period followed by surgery and long-term follow-up to assess the effectiveness and safety of the combination therapy.

Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer