To explore the safety and activity of NALIRIFOX (liposomal irinotecan in combination with fluorouracil, leucovorin, and oxaliplatin) in the perioperative and adjuvant treatment in resectable pancreatic adeneocarcinoma.
previously untreated, histologically or cytologically proven PDAC
age between 20 and 75 years at registration
ECOG performance status of 0 or 1
AJCC (8th edition) clinical stage I or II with measurable disease (CT or MRI) in the pancreas. (positron emission tomography scan alone not allowed)
presence of clinically significant co-morbid medical conditions within 4 weeks prior registration judged by Investigators
severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in past 6 months
New York Heart Association class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure or known abnormal electrocardiogram (ECG) with clinically significant abnormal findings in past 6 months
interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity within 28 days prior to registration
Parallel
NALIRIFOX
DrugPatient in upfront surgery arm will receive operation followed by adjuvant chemotherapy with NALIRIFOX; patient in experimental arm will receive neoadjuvant NALIRIFOX followed by operation than adjuvant NALIRIFOX after operation.
12-month EFS rate
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Taichung Veterans General Hospital
Lead sponsor
National Cheng-Kung University Hospital
Collaborator
Chang Gung Memorial Hospital
Collaborator
Taipei Veterans General Hospital, Taiwan
Collaborator
National Taiwan University Hospital
Collaborator
China Medical University Hospital
Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborator
Tri-Service General Hospital
Collaborator
