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Study of bevacizumab and trifluridine combination given bi-weekly to reduce severe neutropenia in patients with metastatic colorectal cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with metastatic colorectal adenocarcinoma, a type of cancer that has spread beyond the colon or rectum to other parts of the body. The study examines two medications: bevacizumab and trifluridine, which are used in combination to treat this type of cancer. The purpose of the study is to determine if giving these medications on a different schedule (every two weeks) can reduce the occurrence of severely low white blood cell counts (called neutropenia) compared to the standard treatment schedule.

The treatment involves receiving bevacizumab through an intravenous infusion (a drip into the vein) and taking trifluridine as oral tablets. Participants will be randomly assigned to receive either the standard treatment schedule or the new two-weekly schedule. The treatment period may last up to 24 months, during which patients will have regular check-ups to monitor their health and any side effects.

The study will track how often patients experience severe neutropenia with both treatment schedules. Other aspects being monitored include how long patients survive, whether their cancer responds to treatment, and how well patients tolerate the medications. This information will help determine if the new treatment schedule is safer and more effective than the current standard approach.

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

    Initial assessment

    A medical evaluation will be performed, including blood tests and tumor imaging (CT scan or MRI) to confirm eligibility

    Blood tests will check liver function, kidney function, and blood cell counts

    A pregnancy test will be required for women who can become pregnant

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups

    Both groups will receive bevacizumab (given through an intravenous infusion) and trifluridine (taken as oral tablets)

    The difference between groups is in how often the medication is given

  3. Step 3

    Treatment period

    Regular clinic visits will be required for treatment administration and monitoring

    Blood tests will be performed to monitor blood cell counts and other health indicators

    Imaging scans will be conducted to assess how the tumor responds to treatment

    Side effects will be monitored, with special attention to reduced white blood cell counts (neutropenia)

  4. Step 4

    Follow-up assessments

    Regular health assessments will continue throughout the study period

    Your physical condition will be monitored using a scale called ECOG PS

    The study will track how long the treatment remains effective

    The overall duration of the study is expected to continue until January 31, 2029

  5. Step 5

    Safety monitoring

    Any side effects will be recorded and evaluated

    Treatment doses may be adjusted if necessary

    You will be monitored for at least 6 months after completing the treatment

Who can join the trial?

16 criteria

  • Must be at least 18 years old
  • Must have signed and dated informed consent form
  • Must have a life expectancy of at least 3 months
  • Must be able to swallow tablets
  • Must have good blood cell counts: - Sufficient white blood cells (neutrophils >1.5 x 109/L) - Sufficient platelets (>100 x 109/L) - Sufficient hemoglobin (≥9 g/dL)
  • Must have adequate kidney function: - Good creatinine clearance (≥30 mL/min) - Limited protein in urine (<2+ on dipstick test or ≤1g/24h)
  • Must have adequate liver function: - Liver enzymes within acceptable limits - Total bilirubin within normal range - Sufficient albumin levels (≥25 g/L)
  • Must have confirmed stage IV colorectal adenocarcinoma
  • Must have good physical performance status (ECOG 0-1, meaning able to perform daily activities)
  • Must have previously received treatment with specific cancer medications including fluoropyrimidine, oxaliplatin, irinotecan, and targeted therapies
  • Must have at least one measurable tumor that can be evaluated by CT scan or MRI
  • Must have known tumor genetic status (BRAF, RAS, and MSI/dMMR status)
  • For women who can become pregnant: - Must have negative pregnancy test - Must use effective birth control during study and 6 months after - Must not be pregnant or breastfeeding
  • For men who can father children: - Must use effective birth control during study and 6 months after
  • Must be willing to attend all scheduled visits and follow study requirements
  • Must be registered with French National Health Care System or PUMA

Who cannot join the trial?

16 criteria

  • Age below 18 years or above 75 years
  • Known hypersensitivity (allergic reaction) to bevacizumab or trifluridine/tipiracil
  • Presence of active brain metastases (cancer spread to the brain)
  • Severe kidney dysfunction (poor kidney function)
  • Severe liver dysfunction (poor liver function)
  • Uncontrolled high blood pressure
  • Major surgery within the past 28 days
  • Active bleeding or high risk of bleeding
  • Pregnancy or breastfeeding
  • Serious heart conditions, including:
    • Heart attack within the past 6 months
    • Unstable angina (chest pain)
    • Severe heart failure
    • Active infections requiring systemic treatment (medications that affect the whole body)
    • Other active cancers (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
    • Inability to swallow oral medications
    • Any condition that, in the opinion of the investigator, would interfere with the safe conduct of the study
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Investigated drugs

Bevacizumab is a medication used in cancer treatment that works by blocking the formation of new blood vessels that feed tumors. It helps to slow down or stop cancer growth by cutting off the tumor's blood supply. This medication is commonly used in treating various types of cancer, including metastatic colorectal cancer. Trifluridine/tipiracil is a combination medication used to treat advanced colorectal cancer. It works by interfering with cancer cell DNA and preventing cancer cells from growing and multiplying. This medication is typically used when other treatments have not been successful. These medications are being studied together to see if changing how often they are given can reduce the side effect of neutropenia (a decrease in white blood cells that can increase the risk of infection) while maintaining their effectiveness in treating metastatic colorectal cancer.

What is already known about the treatment

  • Bevacizumab

    A targeted cancer medication administered through intravenous infusion that works by blocking the formation of new blood vessels that feed tumors. This monoclonal antibody belongs to the class of anti-angiogenic drugs and is primarily used in the treatment of colorectal cancer, along with other cancer types. It functions by targeting and inhibiting vascular endothelial growth factor (VEGF), effectively starving tumors of their blood supply.

  • Trifluridine/Tipiracil

    An oral combination medication used in the treatment of metastatic colorectal cancer when other treatments have been unsuccessful. This antineoplastic drug works through two mechanisms: trifluridine interferes with DNA synthesis in cancer cells, while tipiracil helps maintain effective levels of trifluridine in the body by preventing its rapid breakdown. The medication is typically administered in cycles and is known to potentially cause neutropenia (low white blood cell count) as a side effect.

Investigated diseases

Colorectal Adenocarcinoma - A type of cancer that begins in the large intestine (colon) or rectum. It develops when cells in the inner lining of the colon or rectum start growing abnormally and form tumors. The disease typically starts as small, benign growths called polyps that can slowly develop into cancer over time. This cancer usually develops gradually, and early stages may not cause noticeable symptoms. As it progresses, it can spread through the layers of the intestinal wall and potentially to other parts of the body. The condition most commonly affects the cells that produce mucus and other fluids in the colon and rectum.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520128-27-00Estimated enrolment162 patientsSponsorAssociation Gercor

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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).