A Multicenter, Single-arm, Open-label Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07 and Serplulimab in the Treatment for RAS/BRAF Wild Type Locally Advanced Rectal Cancer
The study is a multicenter, open-label, phase II clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR)) of patients with RAS/BRAF wild type locally advanced rectal cancer(LARC) treated with short-term radiotherapy, sequential HLX07, Serplulimab and CAPOX. A total of 29 patients were included in this study.
• Patients or their family members agree to participate in the study and sign the informed consent form;
• Age 18-75 years, male or female;
• Histologically confirmed Locally Advanced rectal adenocarcinoma
• Genetic test and/or immunohistochemical confirmation of RAS, BRAF wild type
• inferior margin ≤ 10 cm from the anal verge;
• Pelvic MRI shows high risk \[meets one of the following conditions\]:
‣ Clinical tumor (cT) staging cT4a or cT4b (according to AJCC 8th Edition)
⁃ Extramural vascular infiltration
⁃ Clinical lymph node (cN) staging cN2 (according to AJCC 8th Edition)
⁃ Mesenteric fascia is involved
⁃ Lateral lymph node enlargement 7 ECOG performance status score is 0-1;
∙ 8\. Swallowing pills normally; 9. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc; 10. There was no operative contraindication; 11. Laboratory tests were required to meet the following requirements: white blood cell (WBC) ≥ 4×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet count ≥ 100×109/L; Hemoglobin ≥90 g/L; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL/min; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN 12. Males or females with reproductive ability who are willing to use contraception in the trial;