Research Objective:To investigate the efficacy and safety of the "total neoadjuvant chemoradiotherapy combined with immunotherapy" regimen for the treatment of locally advanced rectal cancer with high-risk features for recurrence.
Study Design:A single-arm, multicenter clinical study.
Study Population: Patients with locally advanced rectal cancer presenting with high-risk features for local recurrence.
Pathologically confirmed rectal adenocarcinoma;
Mid-low rectal cancer, with the lower edge of the tumor located within 12 cm from the anal verge;
Magnetic resonance imaging (MRI) suggests locally advanced rectal cancer (T3 or T4 and M0), accompanied by at least one of the following risk factors: cT4, N2, lymphovascular invasion, involvement of the mesorectal fascia, or enlarged lateral lymph nodes (short-axis diameter > 8 mm); patients with potentially resectable disease;
Polymerase chain reaction (PCR) testing indicates microsatellite stability (MSS) type;
Recurrent rectal cancer;
Synchronous colorectal cancer;
Pregnant or lactating patients;
History of other malignant tumors;