This is a two-arm phase II clinical study to evaluate the efficacy and safety of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced colorectal cancer as the regimen of neoadjuvant treatment. Eligible patients will receive Cadonilimab monotherapy for eight cycles before surgery and part of patients may exempt from surgery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Cadonilimab 10mg/kg iv on day 1 for every 21 days with a total of 8 cycles
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGcomplete response rate
For colon cancer arm, complete response rate include the rate of pathological complete response and clinical complete response; for rectal cancer arm, complete response rate means the rate of clinical complete response
Time frame: 3 years
OS
Overall survival
Time frame: From date of initiation of treatment to date of death due to any cause, assessed up to 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
pCR rate
The rate of pathologic complete response for patients receiving surgery
Time frame: 2 year
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