Standard treatment for patients with proficient mismatch repair (pMMR) / microsatellite stable (MSS) locally advanced rectal cancer (LARC) consists primarily of neoadjuvant chemoradiotherapy followed by radical surgery. Several studies (including the UNION, STELLAR, TORCH, and SPRING-01 trials, etc) have demonstrated that the neoadjuvant strategy of short-course radiotherapy followed by chemotherapy combined with immunotherapy can improve pCR rate in patients with pMMR/MSS LARC, and might also provide higher organ preservation rates and long-term survival benefits. The study aims to explore the efficacy and safety of a TNT regimen comprising short-course radiotherapy combined with chemotherapy, cetuximab N01 (for patients with wild-type RAS/BRAF) or bevacizumab (for patients with mutant RAS/BRAF), and sintilimab in patients with high-risk LARC.
Voluntarily signed the informed consent form.
Aged 18-75 years (inclusive of 18 and 75 years).
pMMR/MSS.
Middle or low rectal cancer located ≤10 cm from the anal verge as assessed by MRI.
Unable to comply with the study protocol or study procedures.
Patients with contraindications to surgery.
Patients with metastatic disease or recurrent rectal cancer.
Uncontrolled active autoimmune disease or active inflammatory disease at enrollment, or receiving immunosuppressive therapy.