The goal of this clinical trial is to evaluate the efficacy of neoadjuvant QL1706 in participants with untreated T4N0 or Stage III (resectable), microsatellite instability high/ defective mismatch repair (MSI-H/dMMR) colon cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
363
Phase Ib/Ⅲ: QL1706 will be administered
Phase Ⅲ:CAPEOX/Capecitabine will be administered
Affiliated Cancer Hospital of Sun Yat-sen University
Guangzhou, 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.
Time frame: 1 month after surgery
Event Free Survival, EFS(EFS), defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery.
Time frame: Up to approximately 5 years
Overall Survival (OS)
OS is defined as time from randomization to death from any cause
Time frame: Up to approximately 5 years
R0 tumor resection rate
R0 tumor resection rate is defined as the proportion of subjects with R0 excision
Time frame: 2 week after surgery
Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-mediated Adverse Event (imAEs), AEs leading to death and AEs leading to discontinuation of study treatment
Time frame: Up to approximately 5 years
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