Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
In ARM Phase Ib Control group, Sintilimab will be used twice, q3w.
In ARM Phase Ib\&III Experimental group,IBI310\&Sintilimab will be used in first cycle, Sintilimab will be used in second cycle(q3w). Radical surgery after neoadjuvant therapy.
In ARM Phase Ib\&III Experimental group, Phase Ib Control group, subjects will receive radical surgery after neoadjuvant therapy. In ARM Phase III Control group,subjects will receive radical surgery without neoadjuvant therapy
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGPathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
The proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
Time frame: 1 month after surgery
Event Free Survival, EFS(EFS), defined as the time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first.
The time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first.
Time frame: up to 5 years after surgery
R0 tumor resection rate, defined as the proportion of subjects with R0 excision
The proportion of subjects with R0 excision
Time frame: 2 week after surgery
Overall-survival(OS), defined as the time from randomization to death from any cause
The time from randomization to death from any cause
Time frame: up to 5 years after surgery
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