The purpose of this study was to evaluate the effect of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) in patients with locally advanced rectal cancer.
Investigator designed a single-arm, open-label, phase II trial and the purpose of this study is to observe and evaluate the efficacy and safety of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) for locally advanced rectal cancer.Participants will accept capecitabine-based long-term radiotherapy(50.4Gy radiation) followed by 200mg Sintilimab each time for 3 times, with 2-week intervals. The primary endpoint is pCR rate, and secondary endpoints include sphincter-preserving rate, adverse event rates.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
45 Gy radiation dose in 25 fractions to the pelvis
200mg Sintilimab after radiation (3 times, 2-week interval)
TME surgery for 6\~8 weeks after radiation
Peking University People's Hospital
Beijing, Beijing Municipality, China
pCR rate
pathological complete response rate
Time frame: within 1 week after surgery
sphincter preserving rate
proportion of patients with preserved anal sphincter
Time frame: instantly after surgery
immune-related adverse event rate
adverse event rate that is deemed to be associated with PD-1 inhibition
Time frame: from commencing of PD-1 inhibition to the 30th day after surgery
treatment-related adverse event rate
adverse event rate that is deemed to be associated with all treatments
Time frame: from commencing of treatment to the 30th day after surgery
incidence rate of surgical complications
incidence rate of surgical complications within 30 days after surgery
Time frame: within 30 days after surgery
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