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Study of FOLFOX6m, Bevacizumab, and Irinotecan for Patients with Colorectal Cancer and Liver Metastases

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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, which is known as metastatic disease. The study involves several medications, including Avastin (bevacizumab), Irinotecan Hydrochloride Trihydrate, Folinic Acid (also known as leucovorin), Erbitux (cetuximab), Oxaliplatin, Fluorouracil, and Vectibix (panitumumab). These medications are used in combination with a procedure called hepatic chemoembolization, which is a treatment that delivers chemotherapy directly to the liver.

The purpose of the study is to evaluate how well these treatments work in reducing the size of liver tumors in patients with colorectal cancer. Participants will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will last for a period of up to 54 weeks, during which the effects of the treatment will be monitored. Some participants may receive a placebo, which is a substance with no active medication, to compare the effectiveness of the treatments.

Throughout the study, the health of the participants will be closely monitored to assess the response of the cancer to the treatment and to check for any side effects. The study aims to understand the overall survival time, which is the time from starting the study to the time of death from any cause, and progression-free survival, which is the time from starting the study to the time the cancer progresses or the participant passes away. The study will also look at the proportion of patients who can undergo surgery to remove liver metastases completely.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the patient meets the study criteria.

  2. Step 2

    Treatment plan discussion

    The treatment plan is explained, including the medications involved and their administration method. The patient is informed about the intravenous infusion process, which is the method used for all medications in this study.

  3. Step 3

    Medication administration

    The patient receives a combination of medications through intravenous infusion. These include bevacizumab, irinotecan hydrochloride trihydrate, folinic acid, cetuximab, oxaliplatin, fluorouracil, and panitumumab. The specific dosage and frequency are determined by the study protocol and the patient's condition.

  4. Step 4

    Regular monitoring

    Throughout the study, the patient's health is regularly monitored. This includes routine blood tests and imaging studies to assess the response to treatment and check for any side effects.

  5. Step 5

    Evaluation of response

    At six months, the patient's response to the treatment is evaluated using imaging techniques. The goal is to measure any changes in tumor size according to specific criteria.

  6. Step 6

    Follow-up visits

    The patient attends follow-up visits to monitor overall health and any long-term effects of the treatment. These visits continue until the end of the study period.

Who can join the trial?

18 criteria

  • Patients must be **18 years or older**.
  • Patients must have **colorectal cancer** with cancer spread only to the liver. This includes:
    • More than **3 cancer spots** in the liver or spots larger than **5 cm**.
    • If the cancer spots are fewer than 3 or smaller than 5 cm, they can still participate if the cancer appeared at the same time as the primary tumor or within **12 months** after surgery for the primary tumor.
    • If the main tumor has not been removed, it must be **clinically stable**, meaning it is not getting worse.
    • The disease must be **measurable** according to specific medical guidelines (RECIST version 1.1).
    • Patients must have **adequate bone marrow function**, which means:
      • **Hemoglobin** (a protein in red blood cells) of at least **9.0 g/dL**. If lower, patients can receive a blood transfusion before joining the study.
      • **Platelet count** of at least **100 x 109 / L**.
      • **Absolute neutrophil count (ANC)** of at least **1.5 x 109 / L**.
      • Patients must have **adequate liver function**, which includes:
        • **Serum bilirubin** (a substance made by the liver) of no more than **1.5 times the upper limit of normal (ULN)**.
        • **ALT** and **AST** (liver enzymes) of no more than **5 times ULN**.
        • **Alkaline phosphatase** of no more than **5 times ULN**.
        • Patients must have **adequate kidney function**, which means:
          • **Creatinine** (a waste product in the blood) of less than **1.5 mg/dL**.
          • **BUN** (blood urea nitrogen) of less than **50 mg/dL**.
          • **Blood urea levels** of less than **18 mmol/L**.
          • **Albumin** (a protein in the blood) of more than **3.0 g/dL**.
          • Patients must have an **ECOG Performance Status** of **0-1**, which means they are fully active or have some symptoms but do not need bed rest during the day.
          • Patients must be able to **understand the study information** and give their **written consent** to participate.
          • Women and men who can have children must agree to **abstain from sexual activity** or use **barrier contraceptive methods** during the study and must have a **negative pregnancy test**.

Who cannot join the trial?

12 criteria

  • Patients with **other types of cancer** besides colorectal cancer.
  • Patients with **cancer spread** to areas other than the liver.
  • Patients with **severe liver disease** not related to cancer.
  • Patients who have had **major surgery** within the last 4 weeks.
  • Patients who are currently receiving **other cancer treatments**.
  • Patients with **uncontrolled infections**.
  • Patients with **severe heart problems**.
  • Patients with **severe kidney problems**.
  • Patients with **severe lung problems**.
  • Patients who are **pregnant or breastfeeding**.
  • Patients who have **allergies** to the study medication.
  • Patients who are **unable to follow** the study procedures.
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Investigated drugs

  • FOLFOX6m

    is a combination chemotherapy treatment used to fight colorectal cancer. It includes a mix of drugs that work together to stop cancer cells from growing and spreading. This treatment is often used when the cancer has spread to other parts of the body, like the liver.

  • Monoclonal Antibody (anti-EGFR)

    is a type of targeted therapy that helps the immune system recognize and attack cancer cells. It specifically targets a protein called EGFR, which is often found on the surface of cancer cells. By blocking this protein, the therapy can slow down or stop the growth of the cancer.

  • Bevacizumab

    is another targeted therapy that works by blocking a protein called VEGF. This protein helps cancer cells form new blood vessels, which they need to grow. By stopping this process, bevacizumab can help slow the growth of the cancer.

  • Lifepearls-Irinotecan

    is a treatment used in a procedure called hepatic chemoembolization. This involves delivering chemotherapy directly to the liver, where it can target cancer cells more effectively. Irinotecan is a chemotherapy drug that works by interfering with the DNA of cancer cells, preventing them from multiplying.

What is already known about the treatment

  • FOLFOX6m

    This medication is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its effectiveness in treating colorectal cancer that has spread to the liver and has a poor prognosis. The main use of FOLFOX6m is to treat certain types of cancer, particularly colorectal cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. FOLFOX6m is classified as a chemotherapy regimen, which is a type of cancer treatment that uses drugs to kill cancer cells.

  • Monoclonal Antibody (anti-EGFR or bevacizumab)

    These medications are given through an IV infusion, which means they are slowly introduced into the bloodstream. They are being tested in clinical trials for their potential to treat colorectal cancer with liver metastases. The primary purpose of these monoclonal antibodies is to target specific proteins on cancer cells, either blocking signals that promote cancer growth or cutting off the blood supply to tumors. They belong to a class of drugs known as targeted therapies, which are designed to attack cancer cells more precisely than traditional chemotherapy.

  • Lifepearls-Irinotecan

    This medication is administered through a procedure called hepatic chemoembolization, where it is delivered directly to the liver. It is under investigation in clinical trials for its role in treating colorectal cancer that has spread to the liver. Lifepearls-Irinotecan is used to target cancer cells in the liver by releasing a chemotherapy drug, irinotecan, directly at the tumor site, which helps to shrink the tumors. It is classified as a form of localized chemotherapy, focusing treatment on a specific area to minimize side effects.

Investigated diseases

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, benign clumps of cells called polyps, which can develop into cancer over time. As the disease progresses, cancer cells can invade and destroy normal tissue nearby. The cancer may spread to other parts of the body, most commonly the liver, lungs, and lymph nodes. Symptoms can include changes in bowel habits, blood in the stool, abdominal discomfort, and unexplained weight loss. The progression of the disease can vary, with some cases remaining localized while others spread more aggressively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517782-16-00Protocol codeGEMCAD-1802Estimated enrolment45 patientsSponsorGrupo Espanol Multidisciplinar En Cancer Digestivo

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).