Irinotecan Liposome Plus Capecitabine and Enronsubemab Combined With Short-course Radiotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer
Trial Parameters
Brief Summary
This is a prospective, single-center, single-arm study on the combination regimen of irinotecan liposome, capecitabine and enronsubemab embedded in short-course radiotherapy as neoadjuvant therapy for locally advanced rectal cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age of 18-75 years old; 2. rectal adenocarcinoma confirmed by histology and/or cytology; 3. locally advanced rectal cancer cT3-4 or N+ confirmed by baseline examination (AJCC/UICC TNM staging (8th edition, 2017); 4. Distance from lower margin to anal margin ≤ 10 cm; 5. Patients with at least one assessable lesion according to RECIST1.1 criteria; 6. ECOG 0-1; 7. the expected survival time was more than 12 months; 8. had not received anti-tumor treatment for rectal cancer after diagnosis, including radiotherapy, chemotherapy, surgery, etc. 9. Bone marrow function: absolute neutrophil count (ANC) ≥1.5×109/L, hemoglobin ≥90g/dL, platelet (PLT) ≥100×109/L, white blood cell (WBC) ≥3.0×109/L; 10. 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; 11. Renal function: serum creatinine (Cr) ≤1.5×ULN or creatin