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New treatment option for Resectable Pancreatic Adenocarcinoma
Official title Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial
ClinicalTrials.gov ID: NCT06816914
What this study is testing
What is NALIRIFOX?
NALIRIFOX is an investigational medicine, being studied as a potential treatment for resectable pancreatic adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 75
You may be able to join if
- 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):
You likely can't join if
- 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...
- interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity...
- presence of diarrhea ≥ CTCAE v.5.0 grade 2
- concomitant systemic infection requiring treatment
See the full eligibility 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kaohsiung City, Taiwan
- Taichung, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
- Taoyuan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kaohsiung City, Taiwan; Taichung, Taiwan; Tainan, Taiwan; Taipei, Taiwan; Taoyuan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.