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.
Age: 18-70 years;
ECOG PS score: 0-1;
Pathologically confirmed rectal adenocarcinoma with immunohistochemistry and/or genetic testing showing MSS/pMMR status;
Lesion located ≤10 cm from the anal verge, confirmed by colonoscopy or digital rectal examination;
Prior pelvic radiotherapy;
Active or progressive infection requiring systemic treatment, such as active tuberculosis or active hepatitis;
Presence of uncontrolled systemic diseases, as determined by the investigator, including diabetes, hypertension, cirrhosis, rheumatological or autoimmune disorders, and severe pulmonary disease;
Clinically significant thyroid dysfunction (based on serum thyroid hormone levels TT4, TT3, FT3, FT4, and serum thyrotropin TSH), deemed unsuitable for study participation by the investigator. (5) History of hemorrhagic or thromboembolic events within the past 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, or spontaneous major bleeding from tumors;
Wang Xin
Lead sponsor
West China Hospital
Sponsor institution