Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in Combination With Cadonilimab for First-Line Treatment of Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study
This study is a single-center, Phase II Study to assess the efficacy and safety of the regimen of Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in combination with Cadonilimab in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.
• Age ≥18, male or female;
• Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
• Has not received prior systemic treatment for their locally advanced or metastatic PDAC;
• Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
• Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
• Has a life expectancy of at least 3 months;
• Has adequate organ function;
• If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
• If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.