This is a two-arm, open label, randomized phase II clinical study. The aim is to evaluate the safety and efficacy of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) combined with XELOX regimen in pMMR locally advanced rectal cancer during the perioperative period. Eligible patients will receive either Cadonilimab plus XELOX or XELOX alone for 4 cycles before and 4 cycles after surgery. The primary endpoint is the pathological complete response rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
10mg/kg iv on day 1, every 21 day
130mg/m2 iv on day 1, every 21 day
1000mg/m2 po bid on day 1 to 14, every 21 day
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGpCR
the rate of pathological complete response
Time frame: 3 years
MPR
the rate of major pathological response according to Becker-TRG
Time frame: 3 years
DFS
disease free survival
Time frame: From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 3 years
OS
overall survival
Time frame: From date of initiation of treatment to date of death, assessed up to 3 years
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