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Study on Bevacizumab-Based Chemotherapy for Patients with Unresectable 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 is focused on studying a treatment for unresectable metastatic colorectal cancer, which is a type of cancer that has spread beyond the colon and cannot be removed with surgery. The treatment being tested involves a medication called Avastin, which contains the active substance bevacizumab. Bevacizumab is a type of protein that helps to slow the growth of new blood vessels that tumors need to grow. In this study, the effect of increasing the dose of Avastin will be evaluated in patients who are receiving it as part of their first-line treatment for this type of cancer.

The purpose of the study is to see if adjusting the dose of Avastin can improve the time patients live without their cancer getting worse, known as progression-free survival. Participants in the study will receive Avastin through an intravenous infusion, which means the medication is given directly into a vein. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects. The study will be conducted over a period of time, with regular check-ups and assessments to monitor the patients' health and the cancer's response to the treatment.

Throughout the study, researchers will also look at other important factors, such as the overall survival of patients, the safety of the treatment, and any side effects that may occur. They will also assess the quality of life of participants and conduct a medical-economic analysis to understand the cost-effectiveness of the treatment. This trial aims to provide valuable information on whether adjusting the dose of Avastin can offer better outcomes for patients with this challenging form of cancer.

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

    Joining the study

    Upon joining the study, the patient must meet specific criteria, including being an adult aged 18 or older, having a confirmed diagnosis of metastatic colorectal cancer that cannot be surgically removed, and being eligible for treatment with bevacizumab.

    The patient must provide informed consent and be affiliated with a French social security system.

  2. Step 2

    Initial treatment phase

    The patient will receive a chemotherapy regimen that includes bevacizumab. This medication is administered as a solution for infusion, which means it is given through a vein.

    The initial dose of bevacizumab is determined based on the patient's needs and medical condition.

  3. Step 3

    Monitoring and dosage adjustment

    On day 14 of the first administration of bevacizumab, the patient's blood will be tested to measure the concentration of the medication.

    If the concentration is 15.5 mg/L or less, the dose of bevacizumab may be doubled to improve treatment effectiveness.

  4. Step 4

    Ongoing treatment and assessments

    The patient will continue to receive bevacizumab infusions at regular intervals, with ongoing monitoring of their health and response to treatment.

    Regular assessments will be conducted to evaluate the progression of the cancer and the patient's overall health, including the safety profile and any side effects experienced.

  5. Step 5

    Evaluation of treatment outcomes

    The primary goal is to assess progression-free survival, which is the length of time during and after treatment that the cancer does not worsen.

    Secondary outcomes include overall survival, tumor response, quality of life, and any potential for surgical removal of metastases.

  6. Step 6

    Completion of the study

    The study is expected to continue until September 2028, with ongoing evaluations of the treatment's effectiveness and safety.

    The patient's participation will contribute to understanding the benefits and risks of adjusting bevacizumab dosage based on individual needs.

Who can join the trial?

18 criteria

  • Adult patients who are at least 18 years old.
  • Must sign a free, written, and informed consent form.
  • Must be affiliated with a French social security system.
  • For the experimental phase, the first residual serum concentration of **bevacizumab** must be 15.5 mg/L or less, measured just before the second infusion on day 14.
  • Must have an **ECOG Performance Status** of 0 to 2, which is a scale that measures how well a patient can perform daily activities.
  • Must have a confirmed diagnosis of metastatic colorectal adenocarcinoma that cannot be surgically removed and is well documented.
  • Bevacizumab treatment must be indicated for the patient.
  • Women of childbearing age must use effective contraception.
  • No previous treatment with palliative chemotherapy for metastatic disease, unless there was a gap of more than 6 months between the end of chemotherapy and relapse.
  • Must have at least one lesion that can be evaluated or measured using a **CT scan** according to specific criteria (RECIST v1.1).
  • Estimated life expectancy must be greater than 3 months.
  • Must have adequate blood, kidney, and liver function, including:
    • Neutrophils (a type of white blood cell) of at least 1.5x109/L.
    • Platelets (cells that help with blood clotting) of at least 100x109/L.
    • Hemoglobin (a protein in red blood cells) of at least 9 g/dL.
    • Serum creatinine (a measure of kidney function) less than 150 μmol/L.
    • Bilirubin (a substance made by the liver) of 1.5 times the upper limit of normal or less.
    • Alkaline phosphatase (an enzyme related to liver function) less than 5 times the upper limit of normal.
    • Proteinuria (protein in urine) less than 2+ on a urine strip or 1 g/24h or less.

Who cannot join the trial?

4 criteria

  • Patients who have already received treatment for their colorectal cancer that cannot be removed by surgery.
  • Patients whose blood level of the drug bevacizumab is more than 15.5 mg/L on the 14th day after the first dose. Bevacizumab is a medication used to treat certain types of cancer.
  • Patients who are not in the age range specified for the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.
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Investigated drugs

Bevacizumab is a medication used in this clinical trial to treat patients with metastatic colorectal cancer that cannot be surgically removed. It is part of a chemotherapy regimen and works by inhibiting the growth of blood vessels that supply nutrients to tumors, thereby slowing or stopping their growth. The trial aims to evaluate the effect of adjusting the dose of bevacizumab based on its concentration in the blood to improve the time patients live without their cancer worsening.

What is already known about the treatment

Bevacizumab – Bevacizumab is administered intravenously and is used in combination with chemotherapy for the treatment of unresectable metastatic colorectal cancer. It is currently well-established in medical literature as a targeted therapy for various cancers. The main therapeutic indication for bevacizumab is as a first-line treatment for metastatic colorectal cancer that cannot be surgically removed. At the molecular level, bevacizumab works by inhibiting vascular endothelial growth factor (VEGF), which reduces the growth of blood vessels that supply nutrients to tumors, thereby slowing tumor growth. It is classified pharmacologically as a monoclonal antibody and an angiogenesis inhibitor.

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 that can develop into cancer over time. As the disease progresses, cancer cells can invade and destroy normal tissue nearby and may spread to other parts of the body. 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 may metastasize to distant organs. Early detection through screening can significantly impact the course of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507873-16-00Protocol codePHARBEVACOLEstimated enrolment122 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

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