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Treatment with trastuzumab deruxtecan, capecitabine and bevacizumab for patients with HER2-positive 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 study focuses on patients with HER2-positive metastatic colorectal cancer. The treatment combines three medications: trastuzumab deruxtecan (also known as T-DXd), capecitabine, and bevacizumab. Trastuzumab deruxtecan is a targeted therapy that specifically works against cancer cells with high levels of HER2 protein. Capecitabine is an oral chemotherapy drug, while bevacizumab is a medication that affects blood vessel growth in tumors.

The purpose of this research is to evaluate how well these three medications work together when given as an initial treatment for metastatic colorectal cancer. The study will measure how many patients respond to this combination therapy. Treatment will continue for up to 12 months, with regular medical check-ups to monitor the patient's health and assess how well the treatment is working.

During the study, trastuzumab deruxtecan and bevacizumab will be given through an intravenous infusion, while capecitabine will be taken as tablets by mouth. Patients will receive regular assessments including physical examinations, blood tests, and imaging scans to monitor their response to treatment and check for any side effects.

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 preparation

    Your tumor tissue will be tested for HER2 presence. This may use existing tissue samples or require a new biopsy

    Basic health tests will be performed, including blood tests, heart function check, and imaging scans to measure tumors

  2. Step 2

    Treatment administration

    You will receive three medications:

    Trastuzumab deruxtecan (Enhertu) through an IV infusion

    Capecitabine as oral tablets

    Bevacizumab through an IV infusion

  3. Step 3

    Regular monitoring

    Regular blood tests will check your blood count, liver, and kidney function

    Heart function tests will be performed periodically

    Imaging scans will track how your tumors respond to treatment

    You will complete quality of life questionnaires

    Side effects will be monitored and recorded

  4. Step 4

    Follow-up period

    After completing treatment, you will need to use birth control for 7 months (women) or 6 months (men)

    Regular check-ups will continue to monitor your health and cancer status

    The study will continue until October 2029

  5. Step 5

    Safety precautions

    You must not become pregnant or father a child during the study

    Women must not breastfeed during the study and for 7 months after

    You must not donate sperm or eggs during the study and follow-up period

Who can join the trial?

13 criteria

  • Must be at least 18 years old
  • Must provide written informed consent before any study procedures
  • Must have confirmed HER2-positive colorectal cancer (a specific protein pattern on cancer cells)
  • Must have known RAS and MMR/MSS status (specific genetic markers) from standard testing
  • Must have waited sufficient time after previous treatments: - 4 weeks after major surgery - 4 weeks after radiation therapy - 3 weeks after chemotherapy - 4 weeks after antibody therapy - 2 weeks after targeted treatments
  • Must have measurable disease that can be evaluated by imaging
  • Must have adequate blood test results showing good: - Blood cell counts - Liver function - Kidney function - Heart function - Blood clotting function
  • Must have a good physical condition (ECOG Performance Status of 0 or 1, meaning able to perform daily activities)
  • Must have a life expectancy of at least 3 months
  • Must provide tumor tissue samples for analysis
  • For women who can become pregnant: - Must have negative pregnancy test - Must use effective birth control during study and 7 months after - Must not breastfeed during study and 7 months after
  • For men with partners who can become pregnant: - Must use contraception during study and 4-6 months after - Must not father children during this period
  • Must be able to comply with all study procedures and follow-up visits

Who cannot join the trial?

14 criteria

  • Prior treatment with HER2-targeted therapy (drugs that target a specific protein involved in cancer growth)
  • History of severe allergic reactions to study medications or similar drugs
  • Active brain metastases (cancer that has spread to the brain) that are not treated or stable
  • Significant heart conditions including heart failure or uncontrolled high blood pressure
  • Major surgery within 4 weeks before starting the study treatment
  • Active or uncontrolled infections
  • Other types of cancer within the last 5 years (except for successfully treated skin cancer or cervical cancer)
  • Severe liver problems or liver dysfunction
  • Severe kidney problems or kidney dysfunction
  • Pregnant or breastfeeding women
  • Unable to swallow oral medications
  • Current participation in other clinical trials
  • Any condition that the study doctor believes would make participation unsafe
  • Known allergy or sensitivity to bevacizumab (a cancer treatment drug) or related substances
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Investigated drugs

  • Trastuzumab-deruxtecan (T-DXd)

    is a targeted medication used to treat HER2-positive cancers. It combines an antibody that targets HER2 proteins on cancer cells with a chemotherapy drug. This medication delivers the chemotherapy directly to cancer cells that have high levels of HER2, potentially reducing damage to healthy cells.

  • Capecitabine

    is an oral chemotherapy medication that belongs to a class of drugs called antimetabolites. It works by interfering with cancer cell growth. The body converts this medication into a form of fluorouracil that helps stop cancer cells from multiplying.

  • Bevacizumab

    is a targeted therapy that works by blocking the formation of new blood vessels that feed tumors. By preventing the growth of these blood vessels, this medication can help slow or stop tumor growth by cutting off the tumor's blood supply.

What is already known about the treatment

  • Trastuzumab-deruxtecan

    A targeted antibody-drug conjugate administered through intravenous infusion, combining trastuzumab (which targets HER2-positive cancer cells) with a potent chemotherapy agent deruxtecan. This medication is used in the treatment of HER2-positive metastatic colorectal cancer, working by delivering the chemotherapy directly to cancer cells that express HER2 proteins on their surface. The drug represents a significant advancement in precision medicine for colorectal cancer treatment, belonging to the class of targeted cancer therapies.

  • Capecitabine

    An oral chemotherapy medication taken in tablet form that converts to 5-fluorouracil (5-FU) in the body. It is commonly used in the treatment of colorectal cancer and works by interfering with cancer cell DNA production, thereby stopping cancer cell growth. This medication belongs to the class of drugs called antimetabolites and is often used in combination with other cancer treatments for enhanced effectiveness.

  • Bevacizumab

    An intravenous biologic medication that works by blocking the formation of new blood vessels that feed tumors. It belongs to a class of drugs called angiogenesis inhibitors and is widely used in the treatment of metastatic colorectal cancer. The medication works by targeting a protein called vascular endothelial growth factor (VEGF), effectively starving the tumor of its blood supply and inhibiting its growth.

Investigated diseases

Metastatic Colorectal Cancer - A condition where cancer that begins in the colon or rectum spreads to other parts of the body. The disease starts when cells in the large intestine grow out of control and form tumors. As the cancer progresses, malignant cells can break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in distant organs, most commonly the liver and lungs. The cancer cells continue to grow and multiply in these new locations, forming additional tumors that affect the function of the invaded organs. This process of cancer spread is what defines the metastatic stage of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519479-24-00Estimated enrolment42 patientsSponsorFondazione GONO G.I.

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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).