54
Participants
Start Date
September 20, 2024
Primary Completion Date
September 20, 2026
Study Completion Date
September 20, 2029
moderately hypofractionated radiotherapy
35 Gy in 10 fractions to mesorectal and metastatic lymph nodes, and 30 Gy in 10 fractions to pelvic lymphatic drainage area, weekly over 5 days at 3-3.5 Gy/day.
chemotherapy
CapeOx-Capecitabine 1000 mg/m² orally twice daily (days 1-14, every 21 days) + Oxaliplatin 130 mg/m² IV (day 1, every 21 days).
immunotherapy
Serplulimab 300 mg IV infusion on day 1 every 21 days.
Total mesorectal excision (TME) surgery
Total mesorectal excision (TME) surgery assessment post 3 cycles of chemotherapy and immunotherapy; eligible patients undergo TME surgery.
Zhongshan Hospital, Fudan University, Shanghai
Shanghai Zhongshan Hospital
OTHER