NCT06396637 PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC

Trial Parameters

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * History of participation of other clinical trials within 4 weeks * Known or suspected allergy to Sintilimab or tetrahydrobiopterin. * Female patients during pregnancy or lactation. * Patients who lack the ability to provide informed consent due to psychological, family, social, or other factors

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