Combined Chemotherapy and Tislelizumab With Preoperative Split-course Hypofraction Radiotherapy for Locally Advanced Rectal Cancer:Study Protocol of a Prospective, Single-arm Phase II Trial
The question of how to administer adequate chemotherapy and immunotherapy to synchronise hypofraction radiotherapy （HFRT） treatment strategy to maximise the benefits of neoadjuvant therapy for the improved prognosis of patients with locally advanced rectal cancer (LARC).We aimed to study whether chemotherapy and tislelizumab plus split-course HFRT results in better outcomes in LARC patients.
• Treatment-naïve patients with operable locally advanced cancer (LARC, T3-4 and/or N+)
• Pathologically diagnosed as rectal adenocarcinoma
• Male or non-pregnant female
• Age: 18-70 years old
• Hematology examination：I. White blood cell count ≥4×10\^9/L;II. Neutrophils ≥1.5×10\^9/L;III. Platelet count ≥100×10\^9/L;IV. Hemoglobin ≥9g/L
• Blood biochemical examination: total bilirubin, AST, ALT≤2.0×upper limit of normal; creatinine≤1.5×upper limit of normal
• Functional status: ECOG score 0-1 points or KPS score ≥70 points
• Obtain the patient's informed consent