Using NALIRIFOX for treating resectable pancreatic cancer before and after surgery

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

This study is testing if a new combination treatment called NALIRIFOX can help people with resectable pancreatic cancer have better surgery results and live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 20 Years to 75 Years
• Sex: All
• Sponsor: Taichung Veterans General Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 9 sites (Kaohsiung City and 8 other locations)
• Trial ID: NCT06816914 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of NALIRIFOX, a combination of liposomal irinotecan, fluorouracil, leucovorin, and oxaliplatin, in patients with resectable pancreatic adenocarcinoma. The study aims to determine if administering this treatment in the perioperative setting can improve surgical outcomes and overall survival rates. By evaluating patients before and after surgery, the trial seeks to address the challenges of initiating adjuvant chemotherapy and managing potential metastases. The goal is to enhance the R0 resection rate and ensure more patients complete their chemotherapy regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 75 with histologically confirmed resectable pancreatic adenocarcinoma and an ECOG performance status of 0 or 1.

Not a fit: Patients with advanced pancreatic cancer or those who have received prior treatment for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates and better management of pancreatic cancer for patients undergoing surgery.

How similar studies have performed: While NALIRIFOX has shown efficacy in metastatic pancreatic cancer, its use in the perioperative setting is novel and has not been extensively tested in prior studies.

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

Where this trial is running

Kaohsiung City and 8 other locations

• Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (RECRUITING)
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (RECRUITING)
• China Medical University Hospital — Taichung, Taiwan (RECRUITING)
• Taichung Veterans General Hospital — Taichung, Taiwan (RECRUITING)
• National Cheng Kung University Hospital — Tainan, Taiwan (RECRUITING)
• National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)
• Taipei Veterans General Hospital — Taipei, Taiwan (RECRUITING)
• Tri-Service General Hospital — Taipei, Taiwan (RECRUITING)
• Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Yan-Shen Shan, MD, PhD — National Cheng-Kung University Hospital
• Study coordinator: Yan-Shen Shan, MD, PhD

Conditions: Resectable Pancreatic Adenocarcinoma, Perioperative, NALIRIFOX, resectable pancreatic adenocarcinoma