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Study on the Effectiveness of Floxuridine in Patients with Resectable Colorectal Liver Metastases and Low Clinical Risk Score

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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 the treatment of colorectal cancer that has spread to the liver, known as colorectal liver metastases. The treatment being tested is called hepatic arterial infusion pump (HAIP) chemotherapy, which involves delivering chemotherapy directly to the liver through a pump. The specific drug used in this treatment is floxuridine, a type of medication that helps to stop cancer cells from growing. The trial aims to compare the effectiveness of surgery combined with HAIP chemotherapy to surgery alone in patients with a low clinical risk score, which means they have a lower chance of the cancer spreading further.

Participants in the study will undergo surgery to remove the liver metastases, and some will receive additional HAIP chemotherapy. The study will monitor how long patients live without the cancer getting worse, known as progression-free survival. Other aspects being observed include overall survival, the occurrence of any side effects, and the quality of life of the participants. The trial will also look at how well the chemotherapy is absorbed and processed by the body, as well as the cost-effectiveness of the treatment.

The study is expected to continue until June 2026, with the goal of providing valuable information on whether adding HAIP chemotherapy to surgery can improve outcomes for patients with colorectal liver metastases. This research could potentially lead to better treatment options for individuals facing this type of cancer.

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

    Joining the study

    Participation begins after meeting specific criteria, including being 18 years or older, having a performance status of 0 or 1, and a clinical risk score of 0-2.

    A confirmed diagnosis of colorectal cancer and liver metastases that can be surgically removed is required.

    A catheter placement for chemotherapy must be feasible based on a CT scan.

  2. Step 2

    Surgery

    Surgical removal of liver metastases is performed.

    This step is crucial for patients with resectable colorectal liver metastases.

  3. Step 3

    Adjuvant chemotherapy

    Chemotherapy is administered using a hepatic arterial infusion pump (HAIP).

    The medication used is floxuridine, delivered directly to the liver through the arterial system.

    This treatment aims to prevent cancer progression and improve survival rates.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up appointments are scheduled to monitor health and detect any cancer progression.

    Progression-free survival and overall survival are assessed.

    Quality of life and any side effects from the treatment are evaluated.

  5. Step 5

    End of trial

    The trial is expected to conclude by June 2026.

    Final assessments will be conducted to evaluate the effectiveness of the treatment.

Who can join the trial?

7 criteria

  • Must be **18 years or older**.
  • Must have an **ECOG performance status** of 0 or 1. This is a scale that measures how well you can perform daily activities. A score of 0 means you are fully active, and a score of 1 means you have some symptoms but can still do light work.
  • Must have a **Clinical Risk Score (CRS)** of 0-2. This score helps assess the risk level of your condition.
  • Must have **colorectal cancer** confirmed by a test called histology, which examines tissue under a microscope.
  • Must have **colorectal liver metastases (CLM)** confirmed by imaging tests, and these must be suitable for surgical removal or a procedure called open ablation.
  • Must be able to have a **catheter placed for HAIP chemotherapy**. This is a special type of chemotherapy delivered directly to the liver, and the placement is checked using a CT scan.
  • Must have **adequate bone marrow, liver, and kidney function**. These are checked with blood tests done within 15 days before joining the study.

Who cannot join the trial?

4 criteria

  • Patients with **extrahepatic disease**, which means cancer that has spread outside the liver, cannot participate.
  • Patients with a **high clinical risk score** above 2 are not eligible. This score helps assess the severity of the disease.
  • Patients who are not within the specified age range for the study cannot join. The study is open to certain age groups only.
  • Patients who are part of a **vulnerable population**, which refers to groups that may need special protection, are not included.
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Investigated drugs

Hepatic Arterial Infusion Pump Chemotherapy is a treatment method used in this trial. It involves delivering chemotherapy directly to the liver through a pump. This approach aims to target liver metastases more effectively by providing a higher concentration of the medication directly to the liver, potentially improving outcomes for patients who have had surgery to remove colorectal cancer that has spread to the liver.

What is already known about the treatment

Hepatic Arterial Infusion Pump Chemotherapy – This treatment is administered directly into the liver through a pump that delivers chemotherapy drugs to the hepatic artery. It is currently being studied in clinical trials for its effectiveness in treating resectable colorectal liver metastases, particularly in patients with a low clinical risk score. The main therapeutic indication is to prevent cancer recurrence after surgical removal of liver metastases. The mechanism of action involves delivering high concentrations of chemotherapy directly to the liver, targeting cancer cells more effectively while minimizing systemic exposure. This method is classified under regional chemotherapy, focusing on localized treatment to enhance efficacy and reduce side effects.

Investigated diseases

Colorectal Liver Metastases – This condition occurs when cancer cells from the colon or rectum spread to the liver. It is a common site for metastasis due to the blood flow from the intestines to the liver. The disease progresses as cancerous cells grow and form tumors in the liver, potentially affecting liver function. Patients may experience symptoms such as abdominal pain, weight loss, or jaundice as the disease advances. The progression can vary, with some cases remaining stable for a period while others may grow more rapidly. The focus is often on managing the spread and maintaining liver function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512850-10-00Estimated enrolment230 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

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