Clinical Trial

Short-course RT Followed by NALIRIFOX Plus Pucotenlimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS/pMMR

Not Yet Recruiting Phase 2
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Summary
The goal of this clinical trial is conducted to evaluate the neoadjuvant regimen of short-course radiotherapy (SCRT) followed by NALIRIFOX chemotherapy plus Pucotenlimab immunotherapy for high-risk locally advanced rectal cancer. The main questions it aims to answer are: 1. Does this regimen increase the complete response rate ? 2. What medical problems (adverse events) do participants have when receiving this treatment? Researchers will evaluate this regimen compared to historical standard neoadjuvant chemoradiotherapy to see if it achieves a higher complete response rate and improves sphincter preservation. Participants will: 1. Receive short-course radiotherapy (25Gy/5f) over 5 consecutive days. 2. Then receive NALIRIFOX chemotherapy every 2 weeks for 9 cycles and Pucotenlimab immunotherapy every 3 weeks for 6 cycles (total treatment duration approximately 6 months). 3. Regular checkups and tests during treatment. 4. Keep a diary of their symptoms and the number of times they use a rescue inhaler.
Trial Details
NCT Number NCT07651007
Lead Sponsor Wang Xin
Conditions Advanced Rectal Cancer
Enrollment 29 participants
Start Date 2026-05-31
Primary Completion 2027-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-16