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Study on the Safety and Effectiveness of Trifluridine/Tipiracil, Capecitabine, and Bevacizumab for Patients with Metastatic Colorectal Cancer Unfit for Intensive Chemotherapy

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 the treatment of metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and has spread to other parts of the body. The study will explore the safety and effectiveness of a combination of medications: Trifluridine/Tipiracil, Capecitabine, and Bevacizumab. Trifluridine/Tipiracil is a medication that comes in the form of film-coated tablets and is taken orally. Capecitabine is another oral medication, while Bevacizumab is given through an intravenous infusion, which means it is administered directly into a vein.

The purpose of this study is to evaluate how well this combination of medications works in patients who have not received chemotherapy for their metastatic colorectal cancer and are not suitable for intensive chemotherapy. The study will involve patients taking these medications over a period of up to 24 months. During this time, researchers will monitor the patients to see how their cancer responds to the treatment and to check for any side effects. The study aims to determine the percentage of patients who experience a reduction in their cancer size, known as the Objective Response Rate.

Participants in the study will be closely observed for any adverse effects, which are unwanted side effects that may occur during treatment. The study will also look at how long patients live without their cancer getting worse, referred to as Progression Free Survival, and overall survival, which is the length of time patients live after starting the treatment. This trial is an important step in understanding how these medications can be used together to treat metastatic colorectal cancer effectively.

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

    Joining the study

    Upon joining the study, the patient provides written consent to participate in the trial procedures.

    A baseline visit is conducted to confirm eligibility, including a blood test for women of childbearing potential to ensure a negative pregnancy result.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of three medications: bevacizumab, capecitabine, and trifluridine/tipiracil.

    Bevacizumab is administered through an intravenous infusion. The specific dosage and frequency are determined by the healthcare provider.

    Capecitabine is taken orally. The dosage and frequency are prescribed by the healthcare provider.

    Trifluridine/tipiracil is available in film-coated tablets and is taken orally. The dosage and frequency are specified by the healthcare provider.

  3. Step 3

    Ongoing treatment and monitoring

    The patient continues to receive the combination treatment as prescribed.

    Regular monitoring is conducted to assess the patient's response to the treatment and to check for any side effects.

    The healthcare team evaluates the Objective Response Rate (ORR), which measures the percentage of patients achieving a complete or partial response to the treatment.

  4. Step 4

    Evaluation of treatment outcomes

    The primary outcome is the Objective Response Rate (ORR), which is assessed according to specific criteria.

    Secondary outcomes include the Overall Toxicity Rate, Progression Free Survival (PFS), and Overall Survival (OS).

    The healthcare team also analyzes patient-reported outcomes to understand the patient's experience during the trial.

  5. Step 5

    Completion of the trial

    The trial is estimated to end by January 3, 2025.

    Upon completion, the healthcare team reviews all collected data to evaluate the safety and effectiveness of the treatment combination.

Who can join the trial?

16 criteria

  • Provide written informed consent to participate in the study.
  • Have a certain level of blood cells: neutrophils (a type of white blood cell) at least 1.5 x 109/L, platelets (cells that help with blood clotting) at least 100 x 109/L, and hemoglobin (a protein in red blood cells) at least 9 g/dl.
  • Have specific liver function levels: total bilirubin (a substance made by the liver) no more than 1.5 times the normal limit, AST and ALT (liver enzymes) no more than 2.5 times the normal limit, or less than 5 times if there are liver metastases, and alkaline phosphatase no more than 2.5 times the normal limit, or less than 5 times if there are liver metastases.
  • Have a creatinine clearance (a measure of kidney function) of at least 50 mL/min or serum creatinine (a waste product in the blood) no more than 1.5 times the normal limit.
  • Male participants with female partners who can become pregnant must agree to use effective birth control methods.
  • Women who can become pregnant must have a negative blood pregnancy test before starting the trial. This includes all women after puberty unless they have not had a period for at least 12 months, are surgically unable to become pregnant, or are not sexually active.
  • Participants and their partners must agree to avoid pregnancy during the trial and for 6 months after the last treatment.
  • Be willing and able to follow the study's rules and procedures.
  • Have a confirmed diagnosis of colorectal cancer through a tissue sample.
  • Have metastatic colorectal cancer (cancer that has spread) that has not been treated with chemotherapy for the spread.
  • Have at least one measurable tumor according to specific guidelines (RECIST1.1).
  • Be at least 18 years old.
  • Have an ECOG PS (a scale to assess how a disease affects daily living abilities) of 1, meaning you are restricted in physically strenuous activity but can carry out light work.
  • Have a life expectancy of at least 12 weeks.
  • Provide available tissue samples from the primary tumor and/or metastases for analysis.
  • Have not been eligible for certain types of chemotherapy combinations before.

Who cannot join the trial?

3 criteria

  • Patients who have already received treatment for their metastatic colorectal cancer cannot participate. This means if you have had any therapy for this type of cancer before, you are not eligible.
  • Patients who are considered fit for intensive chemotherapy are not eligible. Intensive chemotherapy refers to strong cancer treatment that can be hard on the body.
  • Patients who are part of a vulnerable population are not eligible. This means people who might need special protection or care, like those who cannot make decisions for themselves.
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Investigated drugs

  • Trifluridine/Tipiracil

    is a medication used in this trial to help treat metastatic colorectal cancer. It works by interfering with the DNA of cancer cells, which can slow down or stop their growth and spread.

  • Capecitabine

    is another medication included in the trial. It is a type of chemotherapy that is taken orally and is designed to kill cancer cells by interfering with their DNA and RNA, which are essential for cell growth and division.

  • Bevacizumab

    is a therapy used in the trial that targets the blood vessels that supply nutrients to tumors. By blocking these blood vessels, bevacizumab can help starve the cancer cells and prevent them from growing.

What is already known about the treatment

  • Trifluridine/Tipiracil

    This medication is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating metastatic colorectal cancer. It is often used in combination with other drugs to enhance its therapeutic effects. The main therapeutic indication is for patients with metastatic colorectal cancer who are not suitable for intensive chemotherapy. At the molecular level, Trifluridine/Tipiracil works by incorporating into DNA, thereby inhibiting cell division and growth. It is classified as an antineoplastic agent.

  • Capecitabine

    Capecitabine is an oral medication that is part of ongoing clinical trials for metastatic colorectal cancer. It is used to treat various types of cancer, including colorectal cancer, by interfering with the growth of cancer cells. The drug is converted into 5-fluorouracil in the body, which then disrupts DNA synthesis and slows down cancer cell proliferation. Capecitabine is classified as an antimetabolite.

  • Bevacizumab

    Administered intravenously, Bevacizumab is being evaluated in clinical trials for its role in treating metastatic colorectal cancer. It is primarily used to inhibit the growth of blood vessels that supply nutrients to tumors, effectively starving the cancer cells. Bevacizumab works by blocking a protein called vascular endothelial growth factor (VEGF), which is crucial for new blood vessel formation. It is classified as a monoclonal antibody.

Investigated diseases

Metastatic Colorectal Cancer – This disease occurs when cancer that originated in the colon or rectum spreads to other parts of the body, such as the liver or lungs. It typically begins as a growth, or polyp, in the inner lining of the colon or rectum, which can become cancerous over time. As the cancer progresses, it can invade nearby tissues and spread through the lymphatic system or bloodstream to distant organs. Symptoms may include changes in bowel habits, abdominal pain, and unexplained weight loss. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513271-41-00Protocol codeTRICOMBEstimated enrolment36 patientsSponsorFondazione GONO G.I.

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