Efficacy and safety of short-course radiotherapy in total neoadjuvant therapy combined with enlonstobart for pMMR locally advanced rectal cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and Enlonstobart Enlonstobart 200mg IV every 3 weeks; Oxaliplatin 130mg/m2 IV Q3W d1 Capecitabine 1000mg/m2 bid d1-14 q3w
Long-course radiotherapy +Capecitabine 825mg/m2 bid d1-d14, followed by 4 cycles of CAPOX chemotherapy
complete response Rate (pCR+cCR )
Clinical complete response or pathological complete response (cCR or pCR)
Time frame: up to 2 year
Major pathologic response rate
Time frame: up to 2 year
R0 resection rate
Time frame: The R0 resection rate will be evaluated after surgery, an average of 4 weeks
3-year event-free survival (EFS) rate
Time frame: up to 3 years
3-year overall survival (OS)
Time frame: up to 3 years
Adverse Event
Time frame: up to 2 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.