RecruitingPhase 2NCT06816914

Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial

Sponsor

Taichung Veterans General Hospital

Enrollment

84 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

Resectable Pancreatic Adenocarcinoma

Summary

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.

Eligibility

Min Age: 20 YearsMax Age: 75 Years

Inclusion Criteria11

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)
Surgically resectable disease according to NCCN criteria (Version 1.2023 - May 4, 2023):
no arterial tumor contact (celiac axis, superior mesentery artery, or common hepatic artery).
no tumor contact with the superior mesentery vein or portal vein or ≤180° contact without vein contour irregularity.
adequate major organ functions
Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) must agree to use contraception from the time ofinformed consent until 6 months or more after the last dose of investigational products. Also, women must agree not to breastfeed from the time of informed consent until 6 months or more after the last dose of the investigational product.
Men must agree to use contraception from the start of study treatment until 3 months or more after the last dose of the investigational product.
Participants must have signed written informed consent form in accordance with regulatory and institutional guidelines.

Exclusion Criteria14

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
presence of diarrhea ≥ CTCAE v.5.0 grade 2
concomitant systemic infection requiring treatment
prior organ allograft or allogeneic bone marrow transplantation
known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome
prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer
any major surgery within 4 weeks of study treatment. Participants must have recovered from the effects of major surgery or significant traumatic injury at least 4 weeks before study treatment.
pregnant women or nursing mothers, or positive pregnancy tests
severe mental disorder
current use or any use in past 2 weeks of strong cytochrome P450 3A4 enzyme inducers/inhibitors and/or strong UGT1A inhibitors
known hypersensitivity to any of the components of study drugs

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Interventions

DRUGNALIRIFOX

Patient 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.