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Study of fluorouracil, irinotecan and oxaliplatin combination therapy for patients with metastatic pancreatic ductal adenocarcinoma who progressed after gemcitabine treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial aims to evaluate treatments for metastatic pancreatic ductal adenocarcinoma, a type of pancreatic cancer that has spread to other parts of the body. The study will test two different treatment combinations after patients have previously received treatment with gemcitabine alone or combined with Abraxane. The treatments being studied include combinations of medications called fluorouracil, oxaliplatin, and irinotecan, along with supportive medications.

Patients will receive treatment through intravenous infusion, which means the medications will be given directly into a vein. The medications will be administered in cycles over several months. During treatment, doctors will monitor how well the cancer responds and check for any side effects. The main goal is to measure how many patients have their cancer remain stable or improve after about 3 months of treatment.

The study will also track other important factors such as survival time, tumor response, and safety of the treatments. Researchers will collect blood and tissue samples to learn more about how the treatments work. The trial is expected to continue until late 2028.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    You will be randomly assigned to one of two treatment groups for metastatic pancreatic cancer after previous treatment with gemcitabine.

    Your doctor will verify that you meet all health requirements, including adequate kidney, liver, and blood function.

  2. Step 2

    Treatment Group A (5-FU + NALIRI)

    If assigned to this group, you will receive:

    - Fluorouracil (5-FU) through intravenous infusion

    - Naliri (liposomal irinotecan) through intravenous infusion

    The medications will be administered according to a specific schedule determined by your healthcare team.

  3. Step 3

    Treatment Group B (5-FU + NALIRINOX)

    If assigned to this group, you will receive:

    - Fluorouracil (5-FU) through intravenous infusion

    - Naliri (liposomal irinotecan) through intravenous infusion

    - Oxaliplatin through intravenous infusion

    The medications will be administered according to a specific schedule determined by your healthcare team.

  4. Step 3

    Regular monitoring

    Your condition will be monitored through regular medical examinations and tests.

    Imaging scans will be performed to assess how the tumor responds to treatment.

    Blood samples will be taken to monitor your health status.

    The medical team will check for any side effects of the treatment.

  5. Step 4

    Day 85 evaluation

    A key evaluation will occur at day 85 to determine if the cancer has progressed.

    The evaluation will include imaging scans to measure the tumor size.

    Your overall health status will be assessed.

  6. Step 5

    Continued monitoring

    Regular evaluations will continue throughout the study period.

    Treatment may continue as long as it provides benefit and is well-tolerated.

    The study is planned to continue until December 2028.

Who can join the trial?

13 criteria

  • Must be at least 18 years old
  • Must have confirmed pancreatic cancer that has spread to other parts of the body, proven by tissue examination
  • Must have had disease progression after initial treatment with Gemcitabine-Abraxane or Gemcitabine alone
  • Must have a good performance status (ECOG 0 or 1), meaning able to perform daily activities with minimal assistance
  • Must have cancer that can be measured by imaging tests (measurable disease)
  • Must have nerve problems (peripheral neuropathy) less than grade 2 severity
  • Must have adequate:
    • Kidney function (creatinine levels near normal range)
    • Liver function (bilirubin levels near normal range)
    • Blood cell counts (including white cells, platelets, and hemoglobin)
    • Must have normal or near-normal blood clotting tests
    • Must have a life expectancy of at least 12 weeks
    • Must use effective birth control if able to conceive children
    • Must sign an informed consent form

Who cannot join the trial?

14 criteria

  • History of any other cancer within 3 years before starting the study (except for adequately treated non-melanoma skin cancer or carcinoma in situ)
  • Known brain metastases (cancer that has spread to the brain) or active central nervous system disease
  • Major surgery within 4 weeks before starting the study
  • Severe heart conditions, including:
    • Heart attack within the last 6 months
    • Unstable angina (chest pain)
    • Severe heart failure
    • Active, uncontrolled infections requiring treatment
    • Known HIV, active hepatitis B, or active hepatitis C infection
    • Pregnancy or breastfeeding
    • Any psychological, social, or medical condition that would interfere with study participation
    • Previous participation in another clinical trial within 4 weeks before this study
    • Known allergies or severe reactions to similar medications used in this study
    • Severe liver or kidney problems that could affect drug processing in the body
    • Use of medications that could interact with the study treatment
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Investigated drugs

  • 5-FU (Fluorouracil)

    is a chemotherapy medication used to treat various types of cancer. It works by interfering with cancer cell growth and division. In this trial, it serves as a backbone treatment combined with other medications.

  • Naliri

    is an investigational drug being studied in combination with 5-FU for treating pancreatic cancer in patients whose disease has progressed after previous treatment.

  • Nalirinox

    is another investigational treatment combination being studied for pancreatic cancer. It is used in combination with 5-FU for patients whose disease has progressed after previous treatment.

  • Gemcitabine

    is a chemotherapy medication that was used in the patients' previous treatment. It works by preventing cancer cells from making and repairing DNA, which stops them from growing and dividing.

  • Abraxane

    (also known as nab-paclitaxel) is a chemotherapy medication that was previously used in combination with gemcitabine. It works by stopping cancer cells from dividing and growing.

What is already known about the treatment

  • 5-FU (Fluorouracil)

    A chemotherapy medication administered intravenously that belongs to the antimetabolite class of drugs. It works by interfering with DNA synthesis in rapidly dividing cells, effectively stopping cancer cell growth. This drug is commonly used in the treatment of various cancers, including pancreatic ductal adenocarcinoma, and is often combined with other chemotherapy agents for enhanced effectiveness.

  • Nalirinotecan (Naliri)

    A liposomal formulation of irinotecan administered through intravenous infusion, designed to improve the delivery and effectiveness of the traditional irinotecan. It works by inhibiting topoisomerase I, an enzyme essential for DNA replication, thereby preventing cancer cell division. This medication is specifically developed for treating metastatic pancreatic cancer, particularly in patients who have progressed after gemcitabine-based therapy.

  • Gemcitabine

    An intravenously administered chemotherapy drug belonging to the antimetabolite class, which works by replacing one of the building blocks of DNA, causing cancer cell death. It is widely used as a first-line treatment for pancreatic cancer, often in combination with other medications such as Abraxane, and has shown significant effectiveness in treating metastatic pancreatic ductal adenocarcinoma.

  • Abraxane (nab-paclitaxel)

    An albumin-bound formulation of paclitaxel administered intravenously, designed to better target cancer cells while reducing side effects. It works by preventing cancer cell division through disruption of the microtubule network essential for cell division. This medication is commonly used in combination with gemcitabine as a first-line treatment for metastatic pancreatic cancer.

Investigated diseases

Metastatic Pancreatic Ductal Adenocarcinoma - A type of pancreatic cancer that begins in the ducts that carry digestive enzymes and has spread to other parts of the body. The disease starts in the cells lining the pancreatic ducts and grows to form a tumor that can invade nearby tissues. This form of cancer develops when cells in the pancreatic ducts begin to multiply uncontrollably and form masses. The metastatic stage means the cancer cells have spread beyond the pancreas to other organs, commonly the liver, lungs, or nearby lymph nodes. The disease typically affects the body's ability to produce digestive enzymes and hormones that regulate blood sugar.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516336-97-00Protocol codeNALPACEstimated enrolment134 patientsSponsorGroupe Belge D'Oncologie Digestive

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).