This study aims to evaluate the efficacy (pathological complete response rate) of short-course radiotherapy with preservation of tumor-draining lymph nodes followed by sequential PD-1 inhibitor neoadjuvant therapy in patients with stage II-III pMMR/MSS locally advanced rectal cancer.
Age 18-75 years old, regardless of sex.
Fibrocolonoscopy or digital rectal examination indicates that the distal border of the lesion is located 5-10 cm from the anal verge.
Pathologically confirmed rectal adenocarcinoma.
Imaging examinations (including pelvic MRI and chest-abdominal CT) confirm a clinical stage of II/III (cT3-T4aN0 or cT2-4aN+, MRF (-), with no distant metastasis) according to the AJCC Cancer Staging Manual, 8th Edition (2018) (for detailed TNM staging of rectal cancer).
Previous treatment with anti-PD-1/L1, anti-CTLA-4 immunotherapies, or other investigational immunotherapeutic agents is excluded.
Patients with severe autoimmune diseases are excluded, including active inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.
Patients with symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis are excluded.
Patients with clinical or imaging evidence of intestinal obstruction or perforation, or those deemed by the investigator to be at high risk of perforation or hemorrhage, are excluded.
Single group
short-course radiotherapy that preserves tumor-draining lymph nodes
RadiationPatients with stage II-III pMMR/MSS locally advanced rectal cancer receive neoadjuvant therapy with short-course radiotherapy that preserves tumor-draining lymph nodes, followed by 4 cycles of PD-1 inhibitors
pathologic complete response rate
Defined as the absence of residual tumor cells in the surgically resected specimen after neoadjuvant therapy, including both the primary site and lymph nodes.
tumor regression grade
The extent of postoperative tumor regression is graded and assessed according to the American Joint Committee on Cancer (AJCC) criteria, and the proportions of different grades are calculated.
R0 Resection Rate
R0 Resection Rate is defined as the proportion of patients in whom a complete microscopic resection is achieved. Specifically, it indicates that no residual tumor cells are found at the microscopic level on the surgical margin after pathological examination of the resected specimen, also known as a negative microscopic margin.
30-Day Postoperative Complication Rate
30-Day Postoperative Complication Rate is defined as the proportion of patients who experience one or more adverse events directly related to the surgical procedure within the first 30 days after the operation, with the severity of each complication classified according to the Clavien-Dindo Classification system.
3-Year Local-Regional Recurrence Rate
The cumulative incidence of disease recurrence confined to the primary tumor site (local) and/or the regional lymph node basins, assessed at 3 years following surgery. This rate is typically estimated using the Kaplan-Meier method.
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