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Study Comparing Irinotecan, Fluorouracil, Folinic Acid, and Drug Combination for Patients with Metastatic Pancreatic Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying treatments for metastatic pancreatic cancer, a type of cancer that has spread from the pancreas to other parts of the body. The study is testing different combinations of medications to see which is most effective. The medications being studied include 5FU (also known as fluorouracil), LV (also known as folinic acid), Nal-IRI (a form of irinotecan), gemcitabine, and Nab-paclitaxel (a form of paclitaxel). These medications are used to treat cancer by stopping the growth of cancer cells.

The purpose of the study is to compare the effectiveness of these treatments in patients with metastatic pancreatic cancer. Participants will be randomly assigned to one of three groups. One group will receive a combination of Nal-IRI and 5FU/LV, another group will receive gemcitabine and Nab-paclitaxel, and the third group will receive a sequential regimen starting with 5FU/LV and Nal-IRI for two months, followed by gemcitabine and Nab-paclitaxel for another two months. The study will last for up to 12 months, and participants will receive their treatments through an intravenous infusion, which means the medication is given directly into a vein.

The main goal is to see how long patients can live without their cancer getting worse over a period of six months. The study will also look at other factors, such as the overall survival of patients, the response of the tumors to the treatment, and the quality of life of the participants. This information will help doctors understand which treatment combinations might work best for people with metastatic pancreatic cancer.

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

    Joining the study

    Upon joining the study, you will be assigned to one of three groups. Each group receives a different treatment plan for metastatic pancreatic cancer.

    You will be informed about the specific treatment plan you will follow, including the medications and schedule.

  2. Step 2

    Treatment plan arm A

    If assigned to arm A, you will receive a combination of 5FU/LV (fluorouracil and folinic acid) and Nal-IRI (irinotecan) for two months, followed by gemcitabine and Nab-paclitaxel for another two months.

    These medications are administered through an intravenous infusion, which means they are given directly into your bloodstream through a vein.

  3. Step 3

    Treatment plan arm B

    If assigned to arm B, you will receive a combination of 5FU/LV (fluorouracil and folinic acid) and Nal-IRI (irinotecan) continuously.

    These medications are administered through an intravenous infusion.

  4. Step 4

    Treatment plan arm C

    If assigned to arm C, you will receive a combination of gemcitabine and Nab-paclitaxel.

    These medications are administered through an intravenous infusion.

  5. Step 5

    Monitoring and assessments

    Throughout the study, regular monitoring and assessments will be conducted to evaluate your health and the effectiveness of the treatment.

    This includes scans and tests to check the progression of the cancer and any side effects from the treatment.

  6. Step 6

    End of treatment

    At the end of the treatment period, further assessments will be conducted to determine the outcome of the treatment.

    You will be informed about the results and any further steps that may be necessary.

Who can join the trial?

17 criteria

  • Must have a confirmed diagnosis of **pancreatic adenocarcinoma**, which is a type of cancer that starts in the pancreas.
  • Must have a **normal ECG** (electrocardiogram) or an ECG without any significant issues. An ECG is a test that checks for problems with the electrical activity of your heart.
  • Must be able to understand and sign a document that explains the study and gives your permission to participate, known as an **informed consent**.
  • If you are a female who can have children, you must test negative for pregnancy at the start of the study.
  • If you are able to have children, you must agree to use a reliable method of **birth control** during the study and for 7 months after the last dose of the study drug.
  • Must be part of a social security system and able to attend regular follow-up appointments.
  • Must have **metastatic disease**, meaning the cancer has spread to other parts of the body.
  • Must have at least one **measurable lesion** according to specific criteria (RECIST v1.1), which means a tumor that can be measured in size.
  • Must be between the ages of **18 and 75 years**.
  • Must have a **life expectancy** of more than 12 weeks.
  • Must have a **performance status** of less than 2 on the WHO scale, which measures how well you can carry out daily activities.
  • Must not have had prior chemotherapy, except for specific types that ended at least 12 months before joining the study.
  • Must have **well-controlled pain** before joining the study.
  • Must have a certain level of **white blood cells** (ANC ≥ 1,500 cells/μL), **platelets** (≥ 100,000 cells/μL), and **hemoglobin** (≥ 9 g/dL). Blood transfusions are allowed if hemoglobin is below 9 g/dL.
  • Must have **adequate liver function**, shown by normal levels of bilirubin and liver enzymes (AST and ALT). Biliary drainage is allowed if there is a blockage.
  • Must have **albumin levels** of at least 3.0 g/dL. Albumin is a protein in your blood.
  • Must have **normal kidney function**, with a creatinine clearance of at least 50 ml/min. This is a test that measures how well your kidneys are working.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides metastatic pancreatic cancer cannot participate. Metastatic means that the cancer has spread to other parts of the body.
  • Patients who have had another cancer in the past, unless it was a type that is not expected to come back, cannot participate.
  • Patients who have serious heart problems cannot participate.
  • Patients who have uncontrolled infections cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had a recent heart attack cannot participate.
  • Patients who have severe liver disease cannot participate.
  • Patients who have severe kidney disease cannot participate.
  • Patients who have a history of severe allergic reactions to the study drugs cannot participate.
  • Patients who are unable to follow the study procedures cannot participate.
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Investigated drugs

  • Nal-Iri

    is a medication used in this trial to treat metastatic pancreatic cancer. It is a form of irinotecan, which is a type of chemotherapy. This medication works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, it is combined with other medications to see if it can help control the cancer more effectively.

  • 5FU/LV

    is a combination of two medications, 5-fluorouracil (5FU) and leucovorin (LV). 5-fluorouracil is a chemotherapy drug that targets cancer cells and stops them from growing. Leucovorin is used to enhance the effects of 5-fluorouracil, making it more effective in treating cancer. This combination is used in the trial to see how well it works against pancreatic cancer when used with other treatments.

  • Gemcitabine

    is another chemotherapy drug used in this trial. It works by slowing or stopping the growth of cancer cells. Gemcitabine is often used to treat various types of cancer, including pancreatic cancer. In this study, it is combined with other medications to evaluate its effectiveness in controlling the disease.

  • Nab-Paclitaxel

    is a form of the chemotherapy drug paclitaxel, which is bound to a protein called albumin. This formulation helps the drug to be delivered more effectively to the cancer cells. Nab-Paclitaxel works by stopping cancer cells from dividing and growing. It is used in this trial to see if it can improve outcomes for patients with metastatic pancreatic cancer when used with other treatments.

What is already known about the treatment

  • Nal-Iri plus 5FU/LV

    This medication combination is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its effectiveness in treating metastatic pancreatic cancer. The main goal is to see if it can help patients live longer without the cancer getting worse. At the molecular level, Nal-Iri works by inhibiting an enzyme that cancer cells need to grow, while 5FU/LV disrupts the cancer cells' ability to make DNA, which is essential for their growth and survival. This combination falls under the category of chemotherapy, which is a type of cancer treatment that uses drugs to kill cancer cells.

  • Nab-Paclitaxel plus Gemcitabine

    This medication combination is also given intravenously and is being tested for its potential to treat metastatic pancreatic cancer. The focus of the study is to determine if this combination can improve the time patients live without their cancer progressing. Nab-Paclitaxel works by stopping cancer cells from dividing, while Gemcitabine interferes with the DNA of cancer cells, preventing them from multiplying. This combination is classified as chemotherapy, which aims to destroy cancer cells and slow down the disease.

Investigated diseases

Metastatic pancreatic cancer – This disease occurs when cancer that originated in the pancreas spreads to other parts of the body. It typically progresses through the lymphatic system or bloodstream, reaching organs such as the liver, lungs, or peritoneum. As the cancer spreads, it can cause symptoms like abdominal pain, weight loss, and jaundice. The progression of the disease often leads to increased difficulty in managing symptoms and maintaining nutritional intake. Over time, the cancerous cells can form new tumors in the affected organs, further complicating the condition. The disease's advancement is marked by the growth and spread of these tumors, impacting the function of the involved organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-518143-38-00Protocol codeFUNGEMAXEstimated enrolment288 patientsSponsorFondation Franc.Cancerologie Digestive

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