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Study on the Effect of Post-Surgery Chemotherapy with Irinotecan and Drug Combination for Patients with Colorectal Cancer and Liver Metastases

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 metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and spreads to the liver. The study will explore the effects of reintroducing chemotherapy after surgery in patients who have responded well to preoperative chemotherapy. The main goal is to see if this approach can improve the chances of staying free from the disease for three years.

The treatment being studied involves a combination of medications, including FOLFIRI, which is a chemotherapy regimen. This regimen includes irinotecan, fluorouracil, and calcium folinate. Additionally, calcium levofolinate may be used. Other medications that might be part of the treatment are ondansetron, which helps manage nausea, and methylprednisolone, which is used to reduce inflammation. Some patients may receive a placebo as part of the study.

Participants in the study will receive these treatments through intravenous methods, meaning the medications are given directly into a vein. The study will monitor patients over a period to assess their health and any side effects from the treatment. The aim is to determine if the reintroduction of chemotherapy can help patients live longer without the cancer returning, as well as to evaluate overall survival and the safety of the treatment.

The research process

The trial runs in 4 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, eligibility is confirmed based on specific criteria, including age, health status, and previous treatment history.

    The study focuses on patients with colorectal cancer that has spread to the liver.

  2. Step 2

    Treatment phase

    The treatment involves the administration of several medications through intravenous methods.

    The medications include ondansetron, irinotecan, methylprednisolone, fluorouracil, calcium levofolinate, and calcium folinate.

    These medications are part of a chemotherapy regimen known as FOLFIRI, which may be combined with targeted therapy.

    The treatment is administered in cycles, with a total of up to 12 cycles, including preoperative treatment.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess the response to treatment and any side effects.

    The primary goal is to improve the disease-free survival rate at 3 years.

    Secondary goals include overall survival, liver-free survival, and monitoring for any recurrence of cancer.

  4. Step 4

    Completion of the trial

    The trial is expected to conclude by March 2030.

    Upon completion, the results will be analyzed to determine the effectiveness of the treatment in improving survival rates and managing cancer recurrence.

Who can join the trial?

14 criteria

  • The patient must have **colorectal cancer** with **hepatic metastasis**. This means the cancer started in the colon or rectum and has spread to the liver.
  • The cancer in the liver must have been surgically removed with the goal of curing it, and it could not be treated with a specific type of chemotherapy called **oxaliplatin-based chemotherapy** due to cancer-related or tolerance issues.
  • The liver cancer must have returned more than 12 months after the initial treatment of the primary colorectal cancer.
  • The patient must be 18 years old or older.
  • The patient must have a **WHO performance status** of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The patient must be part of a social security scheme.
  • No more than 10 liver tumors should have been treated during surgery.
  • The patient must have received at least 2 cycles and no more than 8 cycles of a specific chemotherapy called **FOLFIRI**, with or without additional targeted therapy, before surgery.
  • This chemotherapy must have been given no more than 12 weeks before the surgery.
  • The surgery must have removed all visible liver tumors, with or without the use of **radiofrequency ablation**, which is a treatment that uses heat to destroy cancer cells.
  • The patient must have shown a positive response to the preoperative therapy, either through imaging tests or tissue examination.
  • There should be no signs of cancer outside the liver or remaining in the liver after surgery, based on a CT scan done within 6 weeks after surgery. A small lung nodule less than 10 mm is not considered a spread of cancer.
  • The primary colorectal cancer or liver metastasis must be tested for specific genetic markers called **RAS** and **BRAF**.
  • The patient must not have any medical reasons that prevent them from receiving FOLFIRI-based chemotherapy.

Who cannot join the trial?

3 criteria

  • Patients who do not have colorectal cancer with hepatic metastasis (cancer that has spread to the liver).
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • FOLFIRI

    is a combination chemotherapy regimen used to treat colorectal cancer. It includes a mix of drugs that work together to stop the growth of cancer cells. This regimen is often used before surgery to shrink tumors and make them easier to remove.

  • Targeted Therapy

    refers to medications that specifically target cancer cells with certain characteristics, such as specific proteins or genes. These therapies aim to attack cancer cells more precisely, potentially causing less harm to normal cells. In this trial, targeted therapy is used alongside FOLFIRI to enhance the treatment's effectiveness against colorectal liver metastases.

What is already known about the treatment

FOLFIRI – This medication is administered intravenously and is used in the treatment of colorectal cancer, particularly in patients with liver metastases. It is currently well-established in medical practice and literature as a chemotherapy regimen. The main therapeutic indication is for colorectal cancer, especially when the cancer has spread to the liver. FOLFIRI works by interfering with the DNA replication process in cancer cells, thereby inhibiting their growth and division. It is classified as a combination chemotherapy regimen, consisting of irinotecan, fluorouracil, and leucovorin.

Investigated diseases

Colorectal Cancer with Hepatic Metastasis – This condition occurs when cancer originating in the colon or rectum spreads to the liver. Initially, colorectal cancer may present with symptoms like changes in bowel habits, abdominal discomfort, or blood in the stool. As the disease progresses and metastasizes to the liver, patients may experience additional symptoms such as jaundice, abdominal swelling, or weight loss. The spread to the liver indicates that cancer cells have traveled through the bloodstream or lymphatic system. The progression of the disease can lead to further complications as the liver's function becomes increasingly compromised. Monitoring and managing the disease's progression is crucial to maintaining quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504831-42-00Protocol codeAPHP220917Estimated enrolment254 patientsSponsorAssistance Publique Hopitaux De Paris

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