Liposomal Irinotecan, Capecitabine, and Enlonstobart Combined With Short-Course Radiotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Prospective, Single-Center, Single-Arm Study
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 at least one assessable lesion according to RECIST1.1 criteria;
• ECOG 0-1;
• the expected survival time was more than 12 months;
• had not received anti-tumor treatment for rectal cancer after diagnosis, including radiotherapy, chemotherapy, surgery, etc.
• Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\^9/L, hemoglobin ≥90g/dL, platelet (PLT) ≥100×10\^9/L, white blood cell (WBC) ≥3.0×10\^9/L;
⁃ Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5 times the upper limit of normal (ULN), if there is liver metastasis ≤5×ULN, total bilirubin \<1.5 ULN;
⁃ Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60mL/min (according to Cockcroft-Gault formula);
⁃ Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5×ULN;
⁃ exclude active or suspected infection;
⁃ non-pregnant or lactating women; Women/men of childbearing age should use effective contraception during the study and for 6 months after the end of study treatment;
⁃ The patients had good compliance, understood the research process of this study, and signed the written informed consent.