Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial
NCT ID: NCT06816914
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
84 participants
INTERVENTIONAL
2025-03-05
2028-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Upfront surgery
Patient in upfront surgery arm will receive operation followed by adjuvant chemotherapy with NALIRIFOX
NALIRIFOX
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.
Perioperative NALIRIFOX
Patient in experimental arm will receive neoadjuvant NALIRIFOX followed by operation than adjuvant NALIRIFOX after operation.
NALIRIFOX
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.
Interventions
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NALIRIFOX
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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National Cheng-Kung University Hospital
OTHER
Chang Gung Memorial Hospital
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
National Taiwan University Hospital
OTHER
China Medical University Hospital
OTHER
Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Tri-Service General Hospital
OTHER
Taichung Veterans General Hospital
OTHER
Responsible Party
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Hsin-Chen Lin
Medical Doctor
Principal Investigators
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Yan-Shen Shan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Cheng-Kung University Hospital
Locations
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SF24596A
Identifier Type: -
Identifier Source: org_study_id
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