This is a prospective, single-center, single-arm study evaluating the combination regimen of liposomal irinotecan, capecitabine, and enlonstobart combined with short-course radiotherapy as neoadjuvant therapy for locally advanced rectal cancer.
Age of 18-75 years old;
rectal adenocarcinoma confirmed by histology and/or cytology;
locally advanced rectal cancer cT3-4 or N+ confirmed by baseline examination (AJCC/UICC TNM staging (8th edition, 2017);
Distance from lower margin to anal margin ≤ 10 cm;
patients with other malignant tumors (except cured carcinoma in situ and basal cell carcinoma) in the past 5 years;
patients with mismatch repair deficiency (dMMR) or microsatellite instability high (MSI-H);
obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding > 30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (fresh blood > 5 mL within 4 weeks), etc. Or treatment for a venous/venous thrombotic event within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulation with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥300 mg/ day or clopidogrel ≥75 mg/ day) may be required.
extensive distant metastasis (e.g., peritoneal metastasis, multiple bone/brain metastases);