Using NALIRIFOX for treating resectable pancreatic cancer before and after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Yan-Shen Shan, MD, PhD — National Cheng-Kung University Hospital
• Study coordinator: Yan-Shen Shan, MD, PhD
• Email: ysshan@mail.ncku.edu.tw
• Phone: 886-6-2353535

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• SMAD4-tailored neoadjuvant therapy for pancreatic cancer that can be surgically removed

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.