A randomized, multicenter, Phase III trial evaluating the efficacy and safety of first-line Sequential AG-mFOLFOX chemotherapy combined with Serplulimab and Bevacizumab versus AG chemotherapy alone in advanced pancreatic cancer. The primary endpoint is Overall Survival (OS). Approximately 292 patients will be enrolled in China.
Voluntarily agree to participate in the study and sign the informed consent;
≥18 years of age and ≤75 years of age on the day of signing the informed consent form, regardless of gender;
Pancreatic ductal adenocarcinoma confirmed by pathologic histology or cytology;
No prior systemic therapy for unresectable locally advanced or metastatic pancreatic cancer;
subjects with clear brain metastases on imaging or with meningeal metastases;
untreated spinal compression fractures not treated by surgery and/or radiotherapy; treated spinal compression fractures require disease stabilization for at least 2 weeks prior to enrollment;
high risk of gastrointestinal or abdominal bleeding as evaluated by the Investigator;
uncontrolled cancer pain; narcotic analgesics not at a stable dose at enrollment;
Parallel
Sequential AG and mFOLFOX in Combination With Serplulimab and Bevacizumab
DrugNab-paclitaxel:125 mg/m2, ivgtt, D1, 8 and 15,every 6 weeks for a treatment cycle Gemcitabine hydrochloride: 1g/m2, ivgtt, D1, 8 and 15,every 6 weeks for a treatment cycle 5-FU: 2400 mg/m2 ,ivgtt over 46h, D29-30, every 6 weeks for a treatment cycle Oxaliplatin: 85 mg/m2 ,ivgtt, D29, every 6 weeks for a treatment cycle LV: 400 mg/m2 ,ivgtt over 2h, D29, every 6 weeks for a treatment cycle Serplulimab Injection: 3mg/kg,ivgtt,D1, every 2 weeks for a treatment cycle. Bevacizumab Injection: 5mg/kg,ivgtt,D1, every 2 weeks for a treatment cycle.
AG chemotherapy
DrugNab-paclitaxel:125 mg/m2, ivgtt, D1, 8 and 15,every 4 weeks for a treatment cycle; Gemcitabine hydrochloride: 1g/m2, ivgtt, D1, 8 and 15, every 4 weeks for a treatment cycle
Overall survival (OS)
The time interval between the start date of study drug and the date of death (any cause)
Objective response rate(ORR)
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)
Progression-free survival (PFS)
Refers to the date from the date of admission to the date of the first progression of disease or death of any cause, using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Disease control rate (DCR)
Percentage of confirmed cases including complete remission (CR), partial remission (PR) and disease stability (SD) among patients with evaluable efficacy
Incidence of Treatment-Emergent Adverse Events
The safety and tolerability profile will be assessed by the incidence of TEAEs. The number and percentage of participants experiencing any TEAE, treatment-related AEs, serious AEs (SAEs), and AEs leading to discontinuation will be summarized. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Dynamics of Peripheral Blood Biomarkers
Changes in blood-based biomarker levels from baseline will be measured. Peripheral blood samples will be used for: 1) Immunophenotyping: The frequency of key immune cell subsets (e.g., CD4+/CD8+ T cells) in PBMCs will be analyzed by flow cytometry. 2) Plasma Multi-omics: Proteins and metabolites will be profiled using proteomics and metabolomics platforms, respectively. Metrics will include the mean change from baseline at each timepoint and the correlation of these changes with clinical response.
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