This is an exploratory study to evaluate the efficacy and safety of neoadjuvant therapy with serplulimab combined with CAPOX and bevacizumab for patients with locally advanced colorectal cancer. The primary endpoint is pathological complete response (pCR). Secondary efficacy endpoints include major pathological response (MPR), R0 resection rate, tumor down-staging, objective response rate (ORR), disease-free survival (DFS), and quality of life, to demonstrate clinical benefit of this combination regimen in the target patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Anti-PD-1 monoclonal antibody, administered intravenously as neoadjuvant therapy.
Combination chemotherapy regimen consisting of capecitabine plus oxaliplatin, administered intravenously as neoadjuvant therapy.
Anti-VEGF monoclonal antibody, administered intravenously as neoadjuvant therapy.
Pathological Complete Response (pCR) Rate
Percentage of patients who achieve pathological complete response, defined as no residual viable tumor cells in the resected surgical specimen.
Time frame: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)
Major Pathological Response (MPR) Rate
Percentage of patients with ≤10% residual viable tumor cells in the resected surgical specimen.
Time frame: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)
R0 Resection Rate
Proportion of patients who undergo complete R0 surgical resection.
Time frame: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)
Tumor Down-staging Rate
Proportion of patients with pathological tumor down-staging compared with baseline clinical staging.
Time frame: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)
Objective Response Rate (ORR)
Proportion of patients with complete or partial response assessed by imaging according to RECIST criteria.
Time frame: Up to 6 weeks after completion of neoadjuvant therapy (prior to surgical resection)
Disease-Free Survival (DFS)
Time from randomization/surgery to disease recurrence or death from any cause.
Time frame: Up to 36 months after surgical resection
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