Colorectal Cancer Clinical Trials

• 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) ≥1.5×109/L, hemoglobin ≥90g/dL, platelet (PLT) ≥100×109/L, white blood cell (WBC) ≥3.0×109/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.