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.
Voluntarily provide written informed consent prior to screening.
Male or female subjects aged ≥18 years.
At least one measurable lesion per RECIST 1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Prior anti-tumor therapy including chemotherapy, radiotherapy, hormonal therapy or molecular-targeted therapy.
Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or other agents targeting T-cell co-stimulatory or immune-checkpoint pathways.
History of other malignant tumors within 5 years or concurrent other malignancies, except for cured carcinoma in situ of cervix, non-melanoma skin cancer, or other malignancies with ≥5 years disease-free survival after curative treatment.
Peripheral neuropathy ≥Grade 2 per NCI-CTCAE v5.0.
Single group
Serplulimab
DrugAnti-PD-1 monoclonal antibody, administered intravenously as neoadjuvant therapy.
CAPOX
DrugCombination chemotherapy regimen consisting of capecitabine plus oxaliplatin, administered intravenously as neoadjuvant therapy.
Bevacizumab
DrugAnti-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.
Major Pathological Response (MPR) Rate
Percentage of patients with ≤10% residual viable tumor cells in the resected surgical specimen.
R0 Resection Rate
Proportion of patients who undergo complete R0 surgical resection.
Tumor Down-staging Rate
Proportion of patients with pathological tumor down-staging compared with baseline clinical staging.
Objective Response Rate (ORR)
Proportion of patients with complete or partial response assessed by imaging according to RECIST criteria.
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