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Study of the safety and use of the Extroducer infusion catheter system for delivering gemcitabine to patients with unresectable locally advanced 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 study focuses on individuals with locally advanced pancreatic cancer that cannot be removed through surgery. The investigation aims to evaluate the safety and performance of a new delivery method for the drug gemcitabine. Instead of standard delivery methods, a specialized infusion catheter system, known as the Extroducer, is used to place the medication into the area immediately surrounding the tumor.

The process involves using the Extroducer to administer gemcitabine directly near the cancerous growth. During the study, researchers will monitor for any serious adverse events, which are unexpected and significant health problems, and track how the body responds to the treatment. The study also looks at changes in tumor markers, which are substances found in the blood that can indicate the presence or activity of cancer, and evaluates the overall quality of life during the course of the treatment.

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

    <b>Initial assessment</b>

    A baseline evaluation is performed to determine the current state of the tumor (the abnormal growth of cells) and to measure the level of CA-19-9, which is a substance in the blood used to monitor certain conditions.

  2. Step 2

    <b>Treatment with infusion catheter</b>

    The Extroducer® Infusion Catheter System, a specialized tube used to deliver medicine, is utilized to administer gemcitabine (a medication used to treat cancer) into the area around or inside the tumor.

  3. Step 3

    <b>Monitoring and follow-up</b>

    Safety is monitored by checking for any serious adverse events (unexpected or severe health problems) within 72 hours after the infusion of gemcitabine.

  4. Step 4

    <b>Ongoing evaluations</b>

    Regular checks are conducted to track the tumor response (how the tumor changes in size or activity) and the levels of CA-19-9 in the blood.

  5. Step 5

    <b>Final assessments</b>

    Between visits 11 and 13, the tumor status and the ability to remove the tumor through surgery are re-evaluated. Quality of life is also assessed using specific questionnaires to understand well-being.

  6. Step 6

    <b>Six-month follow-up</b>

    The survival rates and the time during which the disease does not get worse are evaluated 6 months after the final gemcitabine infusion.

Who can join the trial?

13 criteria

  • You must be at least 18 years old.
  • You must have a confirmed diagnosis of locally advanced pancreatic cancer, which is cancer in the pancreas that has grown into nearby tissues but has not spread to distant parts of the body.
  • The cancer must be unresectable, meaning it cannot be removed through surgery.
  • You must have received intravenous (IV) chemotherapy, which is medicine given directly into a vein, for at least six months.
  • Your cancer must be stable (not growing) or locally progressive (growing only in the immediate area) without showing signs of metastasis, which is the spread of cancer to other parts of the body.
  • Your tumor must be measurable, meaning doctors can clearly see and track its size using specific medical guidelines.
  • You must have an ECOG performance status of 0 or 1, which means you are able to carry out most daily activities and are generally able to walk around without much assistance.
  • You must be able to follow the study schedule, including visits, medical tests, and imaging (like scans), and be able to sign a written informed consent, which is a document where you agree to participate after understanding the details.
  • Your blood counts must be within healthy ranges, including enough neutrophils (a type of white blood cell that fights infection), hemoglobin (a protein in red blood cells that carries oxygen), and platelets (cells that help blood clot).
  • Your liver function must be normal, based on levels of bilirubin and enzymes called AST and ALT.
  • Your kidney function must be healthy, as measured by creatinine (a waste product in the blood) and creatinine clearance (a measure of how well the kidneys filter waste).
  • Women who can become pregnant must have a negative pregnancy test and agree to use effective contraception (methods to prevent pregnancy) during the study.
  • Men who may father a child during the study must agree to use highly effective contraception and must not donate sperm for 3 months after the last treatment.

Who cannot join the trial?

11 criteria

  • You are taking part in another clinical investigation, which is a research study, that might affect the results of this study.
  • You have other unmanaged illnesses, including psychiatric conditions (mental health issues) or difficult social situations, that might make it hard to follow the study rules or could put your health at risk.
  • You are pregnant or nursing.
  • You are unable to provide consent, which means you cannot give legal permission to participate.
  • Your pancreatic tumor is not an adenocarcinoma (a common type of cancer that starts in the glands) but is instead a different type, such as a neuroendocrine tumor or metastases (cancer that has spread).
  • The cancer has spread to other organs or non-regional lymph nodes, which are the small, bean-shaped structures in the body that help fight infection, in areas away from the original tumor.
  • The stage of your cancer is unknown or the cancer has recurrent, meaning it has returned after a period of improvement.
  • You are unable to take Gemcitabine, which is a specific type of chemotherapy medicine used to treat cancer.
  • You have a contraindication to iodine contrast, meaning there is a medical reason why you should not use the special dye often used during imaging tests.
  • There are physical structures in your body that prevent the doctors from reaching the tumor (the mass of cancer cells).
  • You have had or currently have another type of malignancy (cancer), unless you have been free of that cancer for at least 3 years, with some specific exceptions like certain types of skin or bladder cancer.
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Investigated drugs

Gemcitabine is a medication used to treat cancer. In this study, it is being delivered through a special catheter system to reach the area around or inside a tumor.

What is already known about the treatment

Gemcitabine - This medication is a chemotherapy drug administered as a liquid solution through an intravenous infusion. It is a well-established treatment used primarily to fight various types of cancer, including advanced pancreatic cancer. At a molecular level, it works by mimicking the building blocks of DNA, which prevents cancer cells from copying their genetic material and stops them from growing and multiplying. It is pharmacologically classified as an antimetabolite.

Investigated diseases

Unresectable locally advanced pancreatic cancer - This is a type of cancer that begins in the tissues of the pancreas. It occurs when abnormal cells grow uncontrollably and form a tumor that has spread into nearby tissues or blood vessels. Because the tumor is located in a way that makes surgical removal impossible, it is classified as unresectable. The disease often progresses as the cancerous cells continue to multiply and expand within or around the pancreas. Over time, the growth can affect the surrounding organs and various bodily functions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-524733-11-00Protocol codenEXT-GEMEstimated enrolment9 patientsSponsorSmartwise Sweden AB

sourced from the EU Clinical Trials Register and site verification

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