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

NCT06816914 | Recruiting Phase 2

• 1 other identifier: SF24596A
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 9

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.

Conditions

Resectable Pancreatic Adenocarcinoma

Keywords

Perioperative; NALIRIFOX; resectable pancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 12-month EFS rate

  From enrollment to the event in 12 months

Study Arms (2)

Upfront surgery

ACTIVE COMPARATOR

Patient in upfront surgery arm will receive operation followed by adjuvant chemotherapy with NALIRIFOX

Drug: NALIRIFOX

Perioperative NALIRIFOX

EXPERIMENTAL

Patient in experimental arm will receive neoadjuvant NALIRIFOX followed by operation than adjuvant NALIRIFOX after operation.

Drug: NALIRIFOX

Interventions

NALIRIFOX DRUG

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; Upfront surgery

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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):
• 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.

You may not qualify 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 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• National Cheng-Kung University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• National Taiwan University Hospital: collaborator
• China Medical University Hospital: collaborator
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator
• Tri-Service General Hospital: collaborator

Study Sites (9)

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 District, Taiwan

RECRUITING

Study Officials

• Yan-Shen Shan, MD, PhD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan-Shen Shan, MD, PhD

CONTACT

886-6-2353535; ysshan@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 5, 2028
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (9)