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);
Untreated active CNS metastasis or leptomeningeal metastasis.
Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;
Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
Single group
Nanoliposomal Irinotecan+Oxaliplatin +Capecitabine+Cadonilimab
DrugUse the above medications on a regular basis
Objective Response Rate (ORR)
ORR of regimen of NALIRI-XELOX+AK104
Duration of Response (DoR)
Disease Control Rate (DCR)
Median Progression-Free Survival (mPFS)
12-month PFS rate
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