NCT06816914 Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial
| NCT ID | NCT06816914 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Taichung Veterans General Hospital |
| Condition | Resectable Pancreatic Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-03-05 |
| Primary Completion | 2027-02-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 84 participants in total. It began in 2025-03-05 with a primary completion date of 2027-02-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Yan-Shen Shan, MD, PhD
PRINCIPAL INVESTIGATOR
National Cheng-Kung University Hospital
Frequently Asked Questions
Who can join the NCT06816914 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 75 Years, studying Resectable Pancreatic Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06816914 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06816914 currently recruiting?
Yes, NCT06816914 is actively recruiting participants. Contact the research team at ysshan@mail.ncku.edu.tw for enrollment information.
Where is the NCT06816914 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan, Kaohsiung City, Taiwan, Taichung, Taiwan, Taichung, Taiwan and 5 additional locations.
Who is sponsoring the NCT06816914 clinical trial?
NCT06816914 is sponsored by Taichung Veterans General Hospital. The principal investigator is Yan-Shen Shan, MD, PhD at National Cheng-Kung University Hospital. The trial plans to enroll 84 participants.