RecruitingPhase 2NCT06396637

PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC

The Efficacy and Safety of PD-1 Antibody Combined With Sapropterin Dihydrochloride in Patients With Advanced Pancreatic Cancer Who Failed to Standard Treatment.

Sponsor

Sun Yat-sen University

Enrollment

20 participants

Start Date

Apr 30, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Adenocarcinoma Metastatic

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests combining an immune checkpoint drug (anti-PD-1 antibody) with sapropterin dihydrochloride — a drug that helps restore normal metabolism in cancer cells — in patients with pancreatic ductal adenocarcinoma (PDAC), one of the hardest-to-treat cancers. **You may be eligible if...** - You have been diagnosed with pancreatic ductal adenocarcinoma (pancreatic cancer) - You have received prior treatment but your cancer has progressed or returned - You are at least 18 years old with adequate organ function - Your cancer tumor has been tested and expresses certain markers **You may NOT be eligible if...** - You have active autoimmune disease that could flare with immune therapy - You have uncontrolled brain metastases - You are on systemic steroids or other immune-suppressing medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.