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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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Recruiting
31.01.2026

Trial locations

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.

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 ID:
2025-524733-11-00
Protocol code:
nEXT-GEM
Trial Phase:
Human Pharmacology (Phase I) – Other

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