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.
Inclusion Criteria:
Hematology: Hemoglobin ≥ 90 g/L (no transfusion within 14 days); Absolute Neutrophil Count ≥ 1.5 × 10⁹/L; Platelets ≥ 75 × 10⁹/L.
Biochemistry: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 3 × ULN (or ≤ 5 × ULN in the presence of liver metastases); Serum creatinine ≤ 1 × ULN with calculated creatinine clearance > 50 mL/min (Cockcroft-Gault formula).
Coagulation: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN (or within therapeutic range for patients on stable anticoagulation).
Thyroid: Normal TSH, or abnormal TSH with normal FT3/FT4 (e.g., controlled hypothyroidism).
Cardiac: QTc interval (Fridericia's formula) ≤ 450 ms for males and ≤ 470 ms for females.
- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during the study and for 6 months after the last dose. Male participants with female partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose.
Exclusion Criteria:
fairywong04285@163.com13564260428
Patients receive serplulimab 200 mg intravenously (IV) on Day 1 of each 14-day cycle, combined with bevacizumab 6 mg/kg IV on Day 1, plus investigator's choice of either FOLFIRINOX or NALIRIFOX chemotherapy for 8 cycles (16 weeks) as second-line therapy. After the initial 16-week treatment period, patients who achieve disease control (complete response, partial response, or stable disease) based on imaging assessment proceed to maintenance therapy. Maintenance treatment consists of serplulimab 200 mg IV every 2 weeks, bevacizumab 5 mg/kg IV every 2 weeks, and oral S-1 (dose per local clinical practice). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the maximum 2-year serplulimab treatment duration.
Sequential AG and mFOLFOX Combined With Serplulimab Injection and Bevacizumab Injection in Untreated Advanced Pancreatic Cancer
Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases
Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer
Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients
Firstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced Pancreatic Cancer
Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma
Study to Evaluate the Safety and Efficacy of Serplulimab Plus Bevacizumab and Chemotherapy in NSCLC Patients With Brain Metastases
Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma