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Pancreatic AdenocarcinomaPhase 2NCT03483038

A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma

A Phase 2 study testing Liposomal Irinotecan and FOLFOX regimen in people with Pancreatic Adenocarcinoma, run by University of Florida at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable, previously untreated pancreatic adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
Liposomal Irinotecan and FOLFOX regimen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
4 sitesUnited States
Study dates
13 Dec 2018to Dec 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be at least 18 years of age.
  • A new clinical diagnosis of resectable or borderline resectable, previously untreated pancreatic adenocarcinoma confirmed by pathologic specimen evaluation
  • No clinical evidence of metastatic disease
  • Potentially resectable local disease, as confirmed by CT or MRI of the abdomen
  • ECOG performance status of 0 or 1
  • Any biliary obstruction must have been treated.
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  • Subjects with known or suspected Gilbert's disease must be formally tested for UGT1A1*28 with results available to study team prior to treatment initiation
  • Adequate organ function; as defined by:
  • Hematologic-
  • ANC > 1,500 cells/μl without the use of hematopoietic growth factors; and
  • Platelet count > 100,000 cells/μl; and
  • Hemoglobin > 9 g/dL (blood transfusions are permitted for patients with hemoglobin levels below 9 g/dL)
  • Hepatic-
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  • Serum total bilirubin within 1.5 x upper limit of normal (ULN) for the institution, with a trend downwards (biliary drainage is allowed for biliary obstruction),
  • AST and ALT less than or equal to 2.5 x ULN
  • Renal- Serum creatinine less than or equal to 1.5 x ULN
  • Cardiac- Normal ECG or ECG without any clinically significant findings as defined by the treating physician
  • Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 7 months after the last dose of study drug to minimize the risk of pregnancy
  • Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 4 months following the last dose of study drug.

Who cannot join

  • A medical history of prior anti-cancer treatment for pancreatic cancer.
  • Locally advanced unresectable disease or evidence of metastatic disease.
  • Any other invasive malignancy within the past three years.
  • Presence of any known contraindications to or hypersensitivities to the investigational products.
  • Use of strong CYP3A4 inhibitors or inducers which cannot be discontinued prior to study entry.
  • A non-surgical candidate.
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  • Subject is unable to understand, provide consent or comply with study requirements, treatments or instructions in the opinion of the treating physician.
  • Uncontrolled diarrhea, active infection, known interstitial lung disease or other medical condition that precludes safe administration of this combination therapy consistent with manufacturer recommendations.
  • Unwilling/unable to comply with birth control requirements while on study.
  • Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 7 months for females and 4 months for males after the last dose of study drug.
  • Females who are pregnant or breastfeeding.
  • History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
  • Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
  • Known dihydrypyrimidine (DPD) deficiency

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Florida

    Gainesville, Florida, 32608

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Orlando Health UF Health Cancer Center

    Orlando, Florida, 32806

  • Tallahassee Memorial Health Care

    Tallahassee, Florida, 32308

Other trials in United States

About this study

Official title: A Phase II, Open-label Pilot Study Evaluating the Safety and Activity of Liposomal Irinotecan in Combination With 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma (NEO-Nal- IRI Study)

This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable, previously untreated pancreatic adenocarcinoma. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.

Being tested
Liposomal Irinotecan, FOLFOX regimen
Keywords
pancreatic adenocarcinoma, neoadjuvant, ONIVYDE, chemotherapy, borderline resectable, resectable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liposomal IrinotecanDrug

    Also called ONIVYDE

    Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle.

  • FOLFOX regimenDrug

    Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.

Study groups in NCT03483038
Study groupRoleWhat they receive
Liposomal irinotecan with FOLFOXExperimentalSubjects will receive 8 cycles and each cycle is 14 days.
Receives: Drug: Liposomal Irinotecan; Drug: FOLFOX regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Subjects Who Had Post-operative Complications 30 Days Post-surgery

    To determine the percentage of subjects who had post-operative complications 30 days post-surgery. Post-operative complications considered for this outcome measure included hospital readmission, death, second surgery or interventional procedure, or major complications extending hospital stay.

    Measured: 30 days

Secondary outcomes (5)

  1. Percentage of Subjects Who Completed All Intended Cycles of Treatment

    To determine the percentage of subjects that completed all eight intended cycles of treatment with liposomal irinotecan with FOLFOX.

    Measured: 4 months

  2. Percentage of Subjects Who Achieved a Complete Surgical Resection (R0)

    To determine the percentage of subjects who achieved a complete surgical resection (R0),which is determined from review of pathology reports and inclusive of pathologic nodal status and TNM staging. A complete surgical resection (R0) has been achieved when surgical margins are microscopically negative for residual tumor.

    Measured: 7 months

  3. Percentage of Patients Achieving a Best Overall Response of Partial or Complete Response (Objective Response Rate)

    To determine the percentage of patients achieving a best overall response of partial or complete response according to RECIST 1.1 criteria from the start of the treatment until disease progression/recurrence. Per RECIST 1.1 criteria, a complete response is the disappearance of all target lesions (any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm). A partial response is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.

    Measured: 5 months

  4. Difference Between Baseline and Maximal Nadir of Serum CA19-9 Level

    To determine the difference between baseline and maximal nadir of serum CA19-9 level

    Measured: 9 months

  5. Subject Physical, Social, Emotional, and Functional Well-being During Treatment

    To determine subject physical, social, emotional, and functional well-being during treatment, as measured by the FACT-G questionnaire. The FACT-G is a 27 item questionnaire where subjects respond to item with a score of 0-4. The responses to the questions are summed to calculate 4 sub-scores: physical well-being (score range 0-28), social well-being (score range: 0-28), emotional well-being (score range: 0-24), and functional well-being (score range: 0-28). The 4 sub-scores are also summed to calculate the total score. Total scores range from 0-108. A higher sub-score or total score indicates better quality of life. Participants completed the FACT-G at Cycles 1, 5, and 8, as well as at the pre-surgical evaluation and follow-up visits.

    Measured: Cycles 1, 5, and 8 and at pre-surgical evaluation and post-surgical follow-up visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start13 Dec 2018
  3. Primary completion16 Sep 2023
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03483038
Sponsor's protocol ID
UF-STO-PANC-004
Other IDs
IRB201800866 -A, OCR16281
Status last verified
Feb 2026
First submitted
12 Mar 2018
Last updated
27 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • George TJ, Lin T, Nassour I, Rogers SC, Jang T, Sahin I, Ramnaraign BH, Fabregas J, Hitchcock K, Liu G, Russell KB, Turk AA, Kayaleh O, Fan ZH, DeRemer DL, Thomas RM, Lee JH, Hughes SJ. Use of liposomal irinotecan with 5-FU and oxaliplatin (NALIRIFOX) in neoadjuvant pancreatic adenocarcinoma: NEO-Nal-IRI trial. Oncologist. 2026 Aug 6;31(9):oyag250. doi: 10.1093/oncolo/oyag250.

    PubMed 42371783

  • Singhal R, Rogers SC, Lee JH, Ramnaraign B, Sahin I, Fabregas JC, Thomas RM, Hughes SJ, Nassour I, Hitchcock K, Russell K, Kayaleh O, Turk A, Zlotecki R, DeRemer DL, George TJ. A phase II study of neoadjuvant liposomal irinotecan with 5-FU and oxaliplatin (NALIRIFOX) in pancreatic adenocarcinoma. Future Oncol. 2023 Sep;19(27):1841-1851. doi: 10.2217/fon-2023-0256. Epub 2023 Sep 27.

    PubMed 37753702

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Liposomal Irinotecan and FOLFOX regimen in people with Pancreatic Adenocarcinoma, run by University of Florida at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Who Had Post-operative Complications 30 Days Post-surgery (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03483038, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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