This is an investigator-initiated, open-label, single-arm, phase II trial evaluating the efficacy and safety of serplulimab (an anti-PD-1 monoclonal antibody) plus bevacizumab, combined with either FOLFIRINOX or NALIRIFOX chemotherapy, as second-line treatment for metastatic pancreatic ductal adenocarcinoma. The study will enrol up to 34 patients.
Voluntary participation with signed written informed consent, good compliance, and willingness to adhere to follow-up visits.
Age ≥ 18 years, male or female.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 and life expectancy ≥ 3 months.
Histologically or cytologically confirmed locally advanced unresectable or metastatic pancreatic adenocarcinoma.
Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or any other agents specifically targeting T-cell co-stimulation or immune checkpoint pathways.
Prior treatment with bevacizumab or other anti-angiogenic agents. Radiological evidence of major vascular tumor invasion or high risk of fatal hemorrhage; active gastrointestinal bleeding, persistent bleeding disorders, or coagulopathy.
Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, immunotherapy, or molecular targeted therapy within 4 weeks prior to the first dose (bisphosphonates for bone metastases are allowed).
Uncontrolled central nervous system (CNS) metastases (i.e., symptomatic or requiring corticosteroids or mannitol for symptom control).
Single group
Serplulimab and Bevacizumab injection
DrugSerplulimab：200 mg, intravenous infusion, Day 1 of each 14-day cycle Bevacizumab：6 mg/kg (second-line) or 5 mg/kg (maintenance), intravenous infusion, Day 1 of each 14-day cycle
FOLFIRINOX/NALIRIFOX
DrugFOLFIRINOX:Oxaliplatin 68 mg/m² IV over 2h, Irinotecan 130 mg/m² IV over 30-90 min, Leucovorin 400 mg/m² IV over 2h, Fluorouracil 400 mg/m² IV bolus then 2400 mg/m² continuous IV over 46h, Day 1, every 14 days NALIRIFOX:Oxaliplatin 60 mg/m² IV over 2h, Liposomal Irinotecan 50 mg/m² IV over 90 min, Leucovorin 400 mg/m² IV over 30 min, Fluorouracil 2400 mg/m² continuous IV over 46h, Day 1, every 14 days
S-1
DrugOral, dose per local clinical practice, during maintenance phase
Overall Survival (OS)
Overall survival is defined as the time from the date of first study drug administration to the date of death from any cause, assessed by the investigator per RECIST v1.1.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the date of first study drug administration to the date of first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of patients achieving a confirmed complete response (CR) or partial response (PR), as assessed by the investigator per RECIST v1.1.
Duration of Response (DOR)
Duration of response is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Incidence and Severity of Adverse Events (Safety)
Safety and tolerability assessed by the incidence, severity, and relationship of adverse events (AEs), treatment-emergent AEs (TEAEs), and serious adverse events (SAEs); events leading to dose modification or treatment discontinuation; and changes in vital signs, physical examinations, and clinical laboratory parameters. All AEs will be graded per NCI-CTCAE v5.0.
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