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Study of FOLFOX or FOLFIRI chemotherapy with fruquintinib or bevacizumab as second-line treatment for patients with metastatic colorectal cancer

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 study focuses on treating metastatic colorectal cancer, a condition where cancer that started in the colon or rectum has spread to other parts of the body. The study compares two different treatment combinations for patients who have already received one previous treatment. One group will receive FOLFOX or FOLFIRI chemotherapy combined with Fruquintinib (also known as FRUZAQLA), while the other group will receive the same chemotherapy combined with Bevacizumab (also known as Avastin).

The purpose of this study is to evaluate how well these treatment combinations control the disease after 4 months of treatment. FOLFOX chemotherapy includes the drugs fluorouracil, folinic acid, and oxaliplatin, while FOLFIRI chemotherapy includes fluorouracil, folinic acid, and irinotecan. Fruquintinib is taken as capsules by mouth, while the other medications are given through an intravenous infusion into a vein.

The treatment will continue for up to 12 months, with regular medical check-ups and imaging scans to monitor how the cancer responds to treatment. Throughout the study, doctors will track any side effects and how well patients tolerate the treatments. They will also monitor patients' overall health status and quality of life using questionnaires.

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 treatment assignment

    You will be randomly assigned to one of two treatment groups. Both groups receive standard chemotherapy (FOLFOX or FOLFIRI) combined with either fruquintinib or bevacizumab.

    Before starting treatment, you will complete a quality of life questionnaire (EORTC QLQ-C30).

  2. Step 2

    Treatment administration

    If assigned to the fruquintinib group, you will receive hard capsules for oral use along with chemotherapy through intravenous infusion.

    If assigned to the bevacizumab group, you will receive the medication through intravenous infusion along with chemotherapy.

    Your physical condition will be assessed before each treatment cycle.

  3. Step 3

    Regular monitoring

    Your response to treatment will be evaluated through imaging scans at regular intervals.

    Quality of life questionnaires will be completed every 2 months.

    Side effects will be monitored and recorded for up to 30 days after the last treatment dose.

  4. Step 4

    Four-month evaluation

    A major assessment will occur 4 months after starting treatment to evaluate how well the treatment is controlling the disease.

    This evaluation will include imaging scans to measure tumor response.

  5. Step 5

    Ongoing treatment period

    Treatment will continue as long as it remains beneficial and tolerable.

    Regular assessments will continue to monitor disease status and side effects.

    Treatment may be adjusted or discontinued based on how your body responds.

  6. Step 6

    Follow-up period

    After completing treatment, you will continue to be monitored for disease progression.

    Follow-up visits will include health assessments and imaging scans.

    Quality of life assessments will continue during this period.

Who can join the trial?

17 criteria

  • Age between 18 and 80 years old (for patients 75 or older, a special geriatric assessment score must be above 14)
  • Must have received previous treatment with specific medications (Bevacizumab or EGFRi, combined with FOLFOX or FOLFIRI) for colorectal cancer that has spread
  • Must have cancer that cannot be surgically removed
  • Must have at least one tumor that can be measured through imaging
  • Cancer spread (metastases) that cannot be treated with surgery, heat treatment, or targeted radiation
  • Must be able to perform daily activities with minimal assistance (WHO performance status 0 or 1)
  • Must have normal liver function tests
  • Must have a specific genetic type of tumor (BRAF V600E wild type)
  • Must have adequate blood counts: - Hemoglobin level at least 10 g/dL - Platelet count at least 100,000 per microliter - White blood cell count at least 1,500 per microliter
  • Must have adequate kidney function
  • Must have protein in urine below certain levels
  • Life expectancy of at least 3 months
  • Must agree to use effective birth control during the study and for: - Women: 15 months after treatment ends - Men: 12 months after treatment ends
  • Must be able to understand and sign informed consent documents
  • Must have health insurance or social security coverage
  • Must have available tumor tissue sample for testing
  • Must have confirmed diagnosis of colorectal cancer that has spread, with evidence of disease progression on imaging scans

Who cannot join the trial?

13 criteria

  • Having brain metastases (cancer that has spread to the brain) that are not treated or stable
  • Previous treatment with immune checkpoint inhibitors (a type of immunotherapy drug)
  • Active or chronic autoimmune diseases (conditions where the immune system attacks healthy cells)
  • Severe heart conditions including heart failure or uncontrolled high blood pressure
  • Active infections requiring systemic treatment, including hepatitis B, hepatitis C, or HIV
  • Other active cancers requiring treatment (except for treated non-melanoma skin cancer or cervical cancer in situ)
  • Severe liver problems or cirrhosis (scarring of the liver)
  • Severe kidney disease requiring dialysis
  • Bone marrow problems causing low blood cell counts
  • History of organ transplant requiring immunosuppressive medications
  • Pregnant or breastfeeding women
  • Unable to give informed consent
  • Participation in another clinical trial within the last 30 days
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Investigated drugs

  • FOLFOX

    is a combination chemotherapy treatment that includes different medications working together to fight cancer cells. It is commonly used to treat colorectal cancer.

  • FOLFIRI

    is another combination chemotherapy treatment used to treat colorectal cancer. Like FOLFOX, it combines different medications that work in different ways to fight cancer cells.

  • Fruquintinib

    is a targeted therapy medication that works by blocking the formation of new blood vessels that feed cancer cells, helping to slow or stop tumor growth.

  • Bevacizumab

    is a targeted therapy medication that also works by preventing the formation of new blood vessels that supply tumors with nutrients and oxygen. It is often used in combination with other cancer treatments to improve their effectiveness.

What is already known about the treatment

  • Fruquintinib

    An oral small molecule inhibitor used in cancer therapy, specifically developed for treating metastatic colorectal cancer as a second-line treatment. The medication works by selectively inhibiting vascular endothelial growth factor receptors (VEGFR-1, -2, and -3), which play crucial roles in tumor blood vessel formation. It is administered in tablet form and is typically used in combination with standard chemotherapy regimens like FOLFOX or FOLFIRI.

  • Bevacizumab

    A targeted therapy medication administered intravenously that works as a monoclonal antibody designed to inhibit blood vessel growth in tumors. It specifically blocks vascular endothelial growth factor (VEGF), effectively reducing the blood supply to cancer cells and is commonly used in combination with chemotherapy for treating metastatic colorectal cancer. This medication belongs to the class of drugs known as anti-angiogenic agents and has been well-established in clinical practice for various types of cancer treatment.

Investigated diseases

Metastatic Colorectal Cancer – A condition that begins as cancer in the colon or rectum and spreads to other parts of the body. It develops when abnormal cells in the large intestine grow uncontrollably and form tumors that can break away and travel through the bloodstream or lymphatic system to other organs. The cancer typically starts as small growths called polyps on the inner lining of the colon or rectum. As the disease progresses, cancer cells can spread (metastasize) most commonly to the liver, lungs, or distant lymph nodes. The condition can affect both the body's digestive function and the function of organs where the cancer spreads.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522108-26-00Estimated enrolment74 patientsSponsorFondation Franc.Cancerologie Digestive

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