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Yttrium-90 Radioembolization Neoadjuvant Therapy With Immune Marker Profiling and Dosimetry for Potentially Resectable Patients With Colorectal Liver Metastases

NCT07406126 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-02-12

No results posted yet for this study

Summary

This is a observational, prospective, single arm, proof of concept study to assess safety, feasibility, and potential efficacy of combining Yttrium-90 transarterial radioembolization(TARE) with standard systemic therapy in clinical practice for potentially resectable patients with colorectal liver metastases (CRLM). Alternatively, resectability will also be evaluated. The investigators hypothesize that by applying this approach, higher local control and resection rates can be achieved (typically below 13% for patients who are initially deemed unresectable). Additionally, this treatment option is expected to help delay or reduce the need for (a switch in) systemic treatment and eventually improve survival in patients with liver metastases that are not resectable. All studies reporting the results of TARE at ablative doses are retrospective cohort studies or cases series. Prospective data is needed to expand the indications and reimbursement of radioembolization.

Other objectives of the study are:

* To calculate the resection rate in patients undergoing the combined approach.
* To evaluate immune markers in peripheral blood and resected metastases.
* To formulate the first concept of an algorithm, enable to deliver personalized AI assisted dosimetry.
* To assess potential role of circulating tumor DNA (ctDNA) in evaluation of patient prognosis and follow up.
* To determine the grade of necrosis at the time of resection and correlate with the absorbed dose.

Conditions

  • Colorectal Liver Metastases (CRCLM)
  • Unresectable Colorectal Liver Metastases

Interventions

PROCEDURE

Yttrium-90 Radioembolization with standard systemic therapy

Yttrium-90 microspheres are administered through the hepatic artery which supplies blood to tumor tissue (the portal vein supplies blood to the normal hepatic tissue). The microspheres are trapped in the vasculature of the tumor due to arteriolar capillary blockage where they exert a local radiotherapeutic effect. In clinical use, the glass microspheres remain permanently trapped in the vasculature where the isotope decays to infinity leaving background radiation with no therapeutic value. This procedure is combined with standard systemic therapy per routine clinical practice.

Sponsors & Collaborators

  • Instituto de Investigacion Sanitaria La Fe

    collaborator OTHER

  • Boston Scientific International S.A.

    collaborator UNKNOWN

  • Fernando Gómez Muñoz

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07406126 on ClinicalTrials.gov