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Study on Chemotherapy with Liposomal Irinotecan, Oxaliplatin, and 5-Fluorouracil for Patients with Pancreatic Cancer Spread to the Liver

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 a type of cancer called hepatic oligometastatic adenocarcinoma of the pancreas. This is a condition where cancer from the pancreas has spread to the liver but is limited to a few spots. The study is testing a treatment plan that includes a combination of chemotherapy drugs. These drugs are liposomal irinotecan (also known as nal-IRI), oxaliplatin, 5-fluorouracil (also called 5-FU), and folinic acid (also known as leucovorin). The purpose of the study is to see how effective this combination of drugs is when given before surgery to remove the cancer.

Participants in the study will receive the chemotherapy drugs through an intravenous infusion, which means the medicine is given directly into a vein. This treatment will be given over a period of time before the planned surgery to remove the cancer. The study aims to find out if this approach can help improve the chances of successfully removing the cancer and to understand the effects on the patients' quality of life.

The study will also look at how safe the treatment is and monitor any side effects that may occur. The goal is to determine if this treatment can help patients live longer and improve their quality of life. The study is open-label, meaning both the researchers and participants know what treatment is being given, and it is a single-arm study, which means all participants receive the same treatment without a comparison group. A placebo is not used in this study.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of treatment

    Upon joining the study, the patient begins the treatment phase with a combination of medications administered through intravenous infusion.

    The medications include folinic acid, irinotecan (Onivyde pegylated liposomal 4.3 mg/ml), oxaliplatin, and fluorouracil.

  2. Step 2

    Chemotherapy administration

    The patient receives neoadjuvant chemotherapy, which is treatment given as a first step to shrink a tumor before the main treatment.

    This involves the administration of the aforementioned medications through intravenous infusion. The specific dosage and frequency are determined by the healthcare provider based on individual patient needs.

  3. Step 3

    Monitoring and assessment

    Throughout the chemotherapy phase, the patient's response to treatment is closely monitored.

    Regular assessments are conducted to evaluate the efficacy of the treatment and to check for any side effects or adverse reactions.

  4. Step 4

    Surgical resection

    Following the completion of the chemotherapy phase, the patient undergoes a surgical procedure aimed at removing the tumor and any remaining cancerous tissue.

    The goal of the surgery is to achieve what is known as R0/R1 resection, which refers to the complete removal of the tumor with no cancer cells left at the margins of the removed tissue.

  5. Step 5

    Post-surgical follow-up

    After the surgery, the patient enters a follow-up phase where their recovery and overall health are monitored.

    This phase includes regular check-ups and assessments to ensure that the patient is recovering well and to detect any signs of cancer recurrence.

Who can join the trial?

15 criteria

  • The patient must have a confirmed diagnosis of a specific type of pancreatic cancer that has spread to the liver but is limited to 1 to 5 spots, which can be treated or removed. If more than 5 spots are found during surgery, it is still okay if they were not seen in earlier scans.
  • The patient must have a disease that can be measured using a specific method called RECIST v1.1, which helps doctors track the size of tumors.
  • The patient must be able to perform daily activities with little or no help, as measured by a scale called the ECOG performance status, which should be 0 or 1.
  • The patient must have good kidney, liver, and bone marrow function. This includes:
    • A kidney function test result called creatinine clearance of at least 60 mL/min.
    • A liver function test result called total bilirubin of 2 mg/dL or less. If the patient has a tube to help bile flow, the level should be 2 mg/dL or less after the tube is placed.
    • Liver enzymes called ALT and AST should be no more than 5 times the normal limit.
    • A type of white blood cell count called absolute neutrophil count should be at least 1.5 x 109/L.
    • Platelet count, which helps with blood clotting, should be at least 100 x 109/L.
    • Hemoglobin, which carries oxygen in the blood, should be at least 9 g/dL.
    • Blood clotting tests called aPTT and Quick value should be within certain limits.
    • The patient must be 18 years or older when agreeing to join the study.
    • Women who can have children must agree to use very effective birth control or not have heterosexual intercourse during the study and for at least 7 months after the last treatment. This is not needed if they are over 50 and have not had a period for at least 2 years or have been surgically sterilized.
    • Men must agree to use condoms or not have heterosexual intercourse during the study and for at least 6 months after the last treatment. They should also not donate sperm during this time.
    • The patient must provide written consent to participate in the study before any study-specific procedures are done.
    • The patient must be legally able to agree to participate in the study.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have cancer that has spread to more than a few places in the liver.
  • Patients who have had previous treatments that are not allowed in the study.
  • Patients who have other serious health conditions that could affect their safety or the study results.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who are not willing to use effective birth control methods during the study.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have a history of drug or alcohol abuse that could interfere with the study.
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Investigated drugs

  • Liposomal Irinotecan

    is a form of chemotherapy used in this trial. It is designed to help treat cancer by delivering the active drug irinotecan in a liposomal formulation, which can improve the drug's effectiveness and reduce side effects. In this study, it is used as part of a combination therapy to shrink tumors before surgery.

  • Oxaliplatin

    is another chemotherapy drug included in the trial. It works by damaging the DNA of cancer cells, which prevents them from growing and dividing. Oxaliplatin is used in combination with other drugs to enhance the overall treatment effect against pancreatic cancer.

  • 5-Fluorouracil

    is a chemotherapy medication that interferes with the growth of cancer cells. It is often used in combination with other drugs to increase its effectiveness. In this trial, it is part of the treatment regimen aimed at reducing the size of the cancer before surgical removal.

  • Folinic Acid

    is used alongside 5-Fluorouracil to enhance its effects. It helps to stabilize the binding of 5-Fluorouracil to the cancer cells, making the chemotherapy more effective. This combination is a common approach in cancer treatment to improve outcomes.

What is already known about the treatment

  • Liposomal Irinotecan

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating hepatic oligometastatic adenocarcinoma of the pancreas. It is used in combination with other chemotherapy drugs like oxaliplatin and 5-fluorouracil/folinic acid. Liposomal irinotecan works by inhibiting an enzyme called topoisomerase I, which is essential for DNA replication in cancer cells, thereby preventing their growth and division. It belongs to the pharmacological class of topoisomerase inhibitors.

  • Oxaliplatin

    Administered intravenously, oxaliplatin is part of ongoing clinical trials for treating hepatic oligometastatic adenocarcinoma of the pancreas. It is used alongside liposomal irinotecan and 5-fluorouracil/folinic acid. Oxaliplatin works by forming cross-links in DNA, which disrupts the DNA structure and inhibits cancer cell growth. It is classified as a platinum-based chemotherapy drug.

  • 5-Fluorouracil/Folinic Acid

    This combination is given intravenously and is being evaluated in clinical trials for its role in treating hepatic oligometastatic adenocarcinoma of the pancreas. Used with liposomal irinotecan and oxaliplatin, 5-fluorouracil interferes with the synthesis of DNA and RNA by inhibiting the enzyme thymidylate synthase, while folinic acid enhances its effects. It is classified as an antimetabolite chemotherapy agent.

Investigated diseases

Hepatic Oligometastatic Adenocarcinoma of the Pancreas – This disease involves the spread of cancerous cells from the pancreas to the liver, specifically in a limited number of metastatic sites. It originates from adenocarcinoma, which is a type of cancer that forms in mucus-secreting glands and is the most common form of pancreatic cancer. The progression of this disease typically involves the growth and spread of cancer cells from the pancreas to the liver, where they form new tumors. These metastatic tumors can affect liver function and may lead to further complications as they grow. The disease is characterized by its oligometastatic nature, meaning there are only a few metastatic sites, which can influence treatment strategies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512951-18-00Protocol codeUni-Koeln-4067Estimated enrolment150 patientsSponsorUniversity Of Cologne

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