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Study on Chemotherapy with Irinotecan, Folinic Acid, Fluorouracil, Oxaliplatin, and Floxuridine for Patients with Colorectal 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 treatments for colorectal cancer that has spread to the liver, known as liver metastases. The study involves a combination of treatments, including a method called hepatic arterial infusion pump (HAIP) chemotherapy and systemic chemotherapy. The systemic chemotherapy includes medications such as FOLFOX and FOLFIRI, which are combinations of drugs used to treat colorectal cancer. The specific drugs being studied in this trial include irinotecan hydrochloride trihydrate, folinic acid, fluorouracil, oxaliplatin, and floxuridine. The purpose of the study is to determine how feasible it is to use these treatments together in patients with liver-limited colorectal cancer.

Participants in the study will receive the treatments over a period of up to six months. The HAIP chemotherapy involves delivering the drug directly to the liver through a special pump, while the systemic chemotherapy is given through the bloodstream. The study will monitor how well patients tolerate the treatments and whether the cancer becomes operable, meaning it can be surgically removed. The study will also track any side effects or complications that may arise from the treatments.

The trial aims to provide valuable information on the safety and effectiveness of combining HAIP chemotherapy with systemic chemotherapy for patients with colorectal cancer that has spread to the liver. By understanding how these treatments work together, the study hopes to improve outcomes for patients with this type of cancer. The study will continue until 2025, with ongoing assessments of patient responses to the treatment regimen.

The research process

The trial runs in 7 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, the patient will be informed about the trial's objectives and procedures. Written informed consent must be provided, confirming understanding and agreement to participate.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes checking blood counts, liver and kidney function, and overall health status. Imaging tests like CT or MRI scans may be performed to assess the liver condition.

  3. Step 3

    Catheter placement

    A catheter will be placed in the gastroduodenal artery to allow for hepatic arterial infusion pump (HAIP) chemotherapy. This procedure is confirmed as feasible through imaging and a multidisciplinary meeting.

  4. Step 4

    Chemotherapy treatment

    The patient will receive HAIP chemotherapy combined with systemic chemotherapy. The systemic chemotherapy includes drugs such as irinotecan hydrochloride trihydrate, folinic acid, fluorouracil, and oxaliplatin, administered intravenously. The exact dosage and frequency will be determined by the medical team.

    The treatment is planned for at least two cycles, with the duration and specific schedule provided by the healthcare provider.

  5. Step 5

    Monitoring and follow-up

    Throughout the treatment, the patient will be closely monitored for any side effects or complications. Regular follow-up appointments will be scheduled to assess the patient's response to the treatment and adjust the therapy as needed.

    Safety assessments will include monitoring for any adverse events or drug-related toxicities.

  6. Step 6

    Surgical evaluation

    After completing the chemotherapy cycles, the patient will be evaluated for the possibility of surgical intervention. This evaluation will determine if the liver metastases have become resectable, allowing for potential surgical removal.

  7. Step 7

    Post-treatment care

    Following the completion of the study treatment, the patient will receive post-treatment care. This includes monitoring for any long-term effects and ensuring recovery from any surgical procedures if performed.

Who can join the trial?

17 criteria

  • Must be at least 18 years old.
  • Must have adequate bone marrow, liver, and kidney function. This will be checked with blood tests to ensure:
    • Hemoglobin (a protein in red blood cells) is at least 5.5 mmol/L.
    • Absolute neutrophil count (a type of white blood cell) is at least 1.5 * 109/L.
    • Platelets (cells that help with blood clotting) are at least 100 * 109/L.
    • Total bilirubin (a substance made by the liver) is less than 1.5 mg/dL.
    • ASAT and ALAT (liver enzymes) are no more than 5 times the upper limit of normal.
    • Alkaline phosphatase (another liver enzyme) is no more than 5 times the upper limit of normal.
    • Estimated glomerular filtration rate (a measure of kidney function) is more than 45 ml/min.
    • Must provide written informed consent, which means you agree to participate after being informed about the study.
    • Must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest.
    • Must have a life expectancy of at least 12 weeks.
    • Must have a confirmed diagnosis of colorectal adenocarcinoma.
    • Must need first or second line systemic therapy, which is treatment given to control cancer, confirmed by a team of doctors.
    • The cancer must be potentially resectable, meaning it might be possible to remove it with surgery, confirmed by a team of doctors and imaging tests like CT or MRI scans done within 4 weeks before joining the study.
    • It must be technically possible to place a catheter for HAIP chemotherapy, confirmed by a team of liver specialists based on imaging. The catheter is usually placed in a specific artery, and any extra or unusual arteries should be tied off to ensure proper treatment.
    • Must be eligible for abdominal surgery, such as removing the primary tumor or other related surgeries, confirmed by a team of doctors.
    • If the primary tumor is still present, it must be potentially removable by surgery, confirmed by a team of doctors.

Who cannot join the trial?

4 criteria

  • Patients with any medical condition other than colorectal adenocarcinoma cannot participate. Colorectal adenocarcinoma is a type of cancer that starts in the colon or rectum.
  • Patients who have cancer that has spread beyond the liver cannot participate. The study is only for those whose cancer is limited to the liver.
  • Patients who are not within the specified age range cannot participate. The study is for adults only.
  • Patients who are part of a vulnerable population cannot participate. This includes groups who may need special protection or care.
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Investigated drugs

  • FOLFOX

    is a combination of chemotherapy drugs used to treat colorectal cancer. It includes three main medications: 5-fluorouracil, leucovorin, and oxaliplatin. These drugs work together to stop cancer cells from growing and dividing. 5-fluorouracil and leucovorin help to slow down or stop the growth of cancer cells, while oxaliplatin damages the DNA of cancer cells, which can lead to their death. This combination is used to help shrink tumors and slow the progression of the disease.

  • FOLFIRI

    is another combination of chemotherapy drugs used to treat colorectal cancer. It consists of three main medications: 5-fluorouracil, leucovorin, and irinotecan. Like FOLFOX, 5-fluorouracil and leucovorin work to slow down or stop the growth of cancer cells. Irinotecan works by interfering with the DNA of cancer cells, preventing them from dividing and growing. This combination is used to help control the cancer and improve symptoms.

What is already known about the treatment

  • FOLFOX

    FOLFOX is a combination chemotherapy regimen used to treat colorectal cancer, specifically when it has spread to the liver. It is administered intravenously, meaning it is given through a vein, usually in a hospital or clinic setting. The main goal of FOLFOX is to stop cancer cells from growing and dividing. It works by interfering with the DNA inside the cancer cells, which prevents them from multiplying. FOLFOX is classified as an antineoplastic or anticancer treatment.

  • FOLFIRI

    FOLFIRI is another chemotherapy regimen used for treating colorectal cancer, particularly when it has metastasized to the liver. Like FOLFOX, it is given intravenously in a medical facility. FOLFIRI aims to halt the growth of cancer cells by disrupting their DNA, thereby stopping them from spreading. It belongs to the pharmacological class of antineoplastic agents, which are drugs used to combat cancer.

Investigated diseases

Colorectal adenocarcinoma – Colorectal adenocarcinoma is a type of cancer that begins in the glandular cells lining the colon or rectum. It typically starts as a growth called a polyp, which can become cancerous over time. As the disease progresses, the cancer cells can invade deeper layers of the colon or rectum and may spread to nearby lymph nodes. In advanced stages, the cancer can metastasize to other organs, most commonly the liver and lungs. The progression of the disease can lead to symptoms such as changes in bowel habits, blood in the stool, and abdominal discomfort. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-515525-28-00Estimated enrolment31 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

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