Treatment with trastuzumab deruxtecan, capecitabine and bevacizumab for patients with HER2-positive metastatic colorectal cancer

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What is this study about?

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.

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 Treatment administration

You will receive three medications:

Trastuzumab deruxtecan (Enhertu) through an IV infusion

Capecitabine as oral tablets

Bevacizumab through an IV infusion

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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Istituto Oncologico Veneto Padua Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital Del Mar Barcelona Spain
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Hospital Universitario Virgen De Las Nieves Granada Spain
Hopital Prive Jean Mermoz Lyon France
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Groupe Hospitalier Rance Emeraude Saint-Malo France
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie Hamburg Germany
Clntjz Hmejvdoimth Uwaizeqfatyyt Radnj Reims France
Aptieukoim Pxvomnvd Hexdszwg Dy Prkse Paris France
Ivbhdn Idrermua Fpjzsjtqmqaxu Ouadjzwtzxe Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.10.2025
Germany Germany
Not yet recruiting
01.10.2025
Italy Italy
Recruiting
01.10.2025
Spain Spain
Recruiting
01.10.2025

Trial locations

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.

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 ID:
2024-519479-24-00
Trial Phase:
Therapeutic exploratory (Phase II)

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