The Efficacy and Safety of PD-1 Antibody Combined With Sapropterin Dihydrochloride in Patients With Advanced Pancreatic Cancer Who Failed to Standard Treatment.
The prognosis for pancreatic cancer remains dismal, with current guidelines favoring FOLFIRINOX or AG (consisting of Gemcitabine and Abraxane) as the primary chemotherapeutic option. However, research has indicated limited benefits for patients with pancreatic cancer undergoing immunotherapy using Anti-PD-1 antibodies. In this context, researchers aim to investigate the therapeutic potential of Sapropterin Dihydrochloride combined with PD-1 antibody in patients with metastatic pancreatic cancer who failed to standard treatment.
• Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
• Recurrent disease or metastatic disease evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.
• Fail or could not tolerate standard chemotherapy.
• ECOG score 0 or 1.
• Have measurable target lesion.
• Serum total bilirubin level is less than 1.5 x ULN. ALT and AST are less than 2 x ULN. Hemoglobin≥9g/dL, platelet≥75×10\*9/L, white blood count ≥3.0×10\*9/L, neutrophil ≥1.5×10\*9/L. Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate \> 60 mL/min.
• Signed informed consent.