Phase II Study of Nanoliposomal Irinotecan and XELOX Combined With Cadonilimab for First-Line Treatment of Advanced Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Researchers are evaluating the combination of Nanoliposomal Irinotecan and XELOX NALIRI-XELOX with Cadonilimab as a first-line treatment for patients with advanced pancreatic ductal adenocarcinoma PDAC who have not yet received systemic therapy. This Phase II, single-center study aims to assess the safety and effectiveness of this regimen in treating locally advanced or metastatic PDAC. The treatment involves cycles every two weeks including Nanoliposomal Irinotecan, Cadonilimab, Oxaliplatin, and Capecitabine, with specific dosing schedules. After three cycles, patients are re-evaluated, and those treated for more than nine cycles may enter maintenance therapy with Capecitabine and Cadonilimab. This approach studies continuous dosing and maintenance to manage advanced PDAC. Participants will undergo regular assessments including tumor response evaluations according to RECIST 1.1 criteria, safety monitoring for adverse events, and other efficacy measures like progression-free and overall survival over two years. Organ function, performance status, and other health indicators will be closely monitored to track treatment impact and patient safety throughout the study period.

NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC