Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study comparing trifluridine/tipiracil with bevacizumab versus capecitabine with bevacizumab as first-line treatment for patients with metastatic colorectal cancer who cannot receive intensive therapy

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study focuses on patients with metastatic colorectal cancer who cannot receive intensive therapy. The research compares two different treatment combinations. The first combination includes trifluridine/tipiracil with bevacizumab, while the second combines capecitabine with bevacizumab. Metastatic colorectal cancer occurs when cancer that starts in the colon or rectum spreads to other parts of the body.

The main purpose of this study is to determine if the combination of trifluridine/tipiracil with bevacizumab works better than capecitabine with bevacizumab as a first treatment option. The medications are given in different ways - some are taken as tablets by mouth, while bevacizumab is given through an intravenous line (directly into a vein).

During the study, doctors will monitor how the disease responds to treatment and track any side effects that may occur. They will also evaluate how the treatments affect patients' overall health and quality of life. The study is "open-label," which means both doctors and patients know which treatment is being given.

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 treatment assignment

    You will be randomly assigned to one of two treatment groups for your metastatic colorectal cancer

    Both groups receive bevacizumab through intravenous infusion

    Group 1 receives trifluridine/tipiracil (Lonsurf) tablets by mouth

    Group 2 receives capecitabine (Xeloda) tablets by mouth

  2. Step 2

    Treatment administration

    You will receive regular doses of the assigned medications

    Bevacizumab is given through an intravenous infusion at the treatment center

    The tablets (either Lonsurf or Xeloda) are taken at home according to the prescribed schedule

    Treatment continues until your condition shows progression or you experience unacceptable side effects

  3. Step 3

    Regular monitoring

    Your doctor will perform regular physical examinations

    Laboratory tests will check your blood counts and organ function

    Heart monitoring through ECG (heart rhythm test) will be conducted

    Your overall health status will be assessed using the ECOG scale (a measure of daily living abilities)

    Imaging scans will track how your cancer responds to treatment

  4. Step 4

    Quality of life assessment

    You will complete questionnaires about your well-being and daily activities

    Any side effects or health changes will be recorded and monitored

  5. Step 5

    Study completion

    The study continues until June 2025

    Your participation ends if your disease progresses or you experience unacceptable side effects

    A final evaluation will be conducted when your participation ends

Who can join the trial?

12 criteria

  • Must have confirmed adenocarcinoma (a type of cancer that starts in gland cells) of the colon or rectum, with known location of the primary tumor
  • Must have RAS status (a genetic test that helps determine treatment options) from tumor testing available or have tissue sample available for testing
  • Not suitable for standard full-dose combination chemotherapy with irinotecan or oxaliplatin (types of chemotherapy drugs)
  • Cannot have cancer that can be removed through surgery
  • No previous cancer treatments for metastatic colorectal cancer (cancer that has spread to other parts of the body)
  • Must have an ECOG performance status of 2 or less (a scale that measures a patient's ability to perform daily activities, where 0 is fully active and 2 means able to do light activities but unable to work)
  • Must have adequate organ function, including:
    • Proper kidney function
    • Normal blood cell counts
    • Adequate liver function
    • Normal blood clotting
    • Both men and women may participate
    • Must be an adult (18 years or older)

Who cannot join the trial?

16 criteria

  • Prior chemotherapy for metastatic colorectal cancer (cancer that has spread to other parts of the body)
  • History of bevacizumab (a cancer treatment medication) intolerance or allergic reactions
  • Active brain metastases (cancer that has spread to the brain)
  • Severe heart conditions in the past 6 months, including:
    • Heart attack
    • Unstable chest pain
    • Severe heart rhythm problems
    • Uncontrolled high blood pressure (above 150/90 mmHg despite medication)
    • Major surgery within 28 days before starting the study
    • Active bleeding or high risk of bleeding
    • Serious infections requiring antibiotics
    • Known infection with HIV, hepatitis B, or hepatitis C
    • Other active cancers in the past 5 years (except for adequately treated skin cancer or cervical cancer)
    • Pregnancy or breastfeeding
    • Unable to swallow oral medications
    • Severe kidney or liver problems
    • Any condition that, in the doctor's opinion, would make participation unsafe
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Trifluridine/tipiracil (S 95005)

    is a combination medication used to treat colorectal cancer. It works by interfering with cancer cell growth and division. This medication is taken orally and helps slow down the progression of cancer in patients who have metastatic colorectal cancer.

  • Bevacizumab

    is a targeted therapy medication that works by blocking the formation of new blood vessels that feed tumors. By preventing the growth of these blood vessels, it helps slow down or stop cancer growth. It is given through an intravenous (IV) infusion.

  • Capecitabine

    is an oral chemotherapy medication that converts to an active form inside cancer cells. It works by interfering with cancer cell DNA production and growth. This medication is commonly used to treat various types of cancer, including colorectal cancer.

What is already known about the treatment

  • Trifluridine/tipiracil (S 95005)

    An oral combination medication used in the treatment of metastatic colorectal cancer, particularly for patients who are not candidates for intensive therapy. This drug works by combining trifluridine, a nucleoside metabolic inhibitor that interferes with DNA synthesis, and tipiracil, which helps maintain effective levels of trifluridine in the body. It belongs to the class of antineoplastic (anti-cancer) agents and is typically administered in combination with bevacizumab as part of a first-line treatment regimen.

  • Bevacizumab

    An intravenously administered targeted therapy medication that works by blocking the formation of new blood vessels that supply tumors with nutrients and oxygen. This monoclonal antibody specifically targets vascular endothelial growth factor (VEGF) and is commonly used in combination with other cancer treatments for metastatic colorectal cancer. It belongs to the class of anti-angiogenic agents and has demonstrated effectiveness in improving progression-free survival when combined with other chemotherapy medications.

  • Capecitabine

    An oral chemotherapy medication that converts to 5-fluorouracil (5-FU) in the body, specifically targeting rapidly dividing cancer cells. This drug belongs to the class of fluoropyrimidines and acts as an antimetabolite, interfering with DNA and RNA synthesis in cancer cells. It is commonly used in combination with bevacizumab as a standard treatment option for metastatic colorectal cancer, particularly in patients who require a less intensive therapeutic approach.

Investigated diseases

Metastatic colorectal cancer – A condition that begins as cancer in the colon or rectum and spreads to other parts of the body. The disease starts when cells in the large intestine begin to grow uncontrollably and form tumors. These cancer cells can break away from the original tumor and travel through the blood or lymph system to form new tumors in other organs. It most commonly spreads to the liver, but can also affect the lungs, bones, and other organs. The disease typically develops gradually over time, starting as small growths called polyps in the inner lining of the colon or rectum, which can eventually become cancerous and spread beyond the original site.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516180-85-00Protocol codeCL3-95005-006Estimated enrolment466 patientsSponsorInstitut De Recherches Internationales Servier IRIS

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.