NCT07406126: YRENE

Y90 Radioembolization as Neoadjuvant Therapy for Potentially Resectable Patients With Colorectal Liver Metastases: Immune Markers Evaluation, Impact on Circulating Tumor DNA and Personalized Dosimetry Approach

Not yet recruiting Last updated 9 February 2026

What this trial tests

trial testing Yttrium-90 Radioembolization with standard systemic therapy in Colorectal Liver Metastases (CRCLM) in 30 participants. Not yet recruiting.

Timeline

1 February 2026

Primary endpoint
1 July 2028

1 July 2028

Quick facts

Lead sponsor	Fernando Gómez Muñoz
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	30
Start date	1 February 2026
Primary completion	1 July 2028
Estimated completion	1 July 2028
Sites	5 locations across Spain

Drugs / interventions tested

• Yttrium-90 Radioembolization with standard systemic therapy

Conditions studied

• Colorectal Liver Metastases (CRCLM) — all drugs for Colorectal Liver Metastases (CRCLM) →
• Unresectable Colorectal Liver Metastases — all drugs for Unresectable Colorectal Liver Metastases →

Sponsor

Fernando Gómez Muñoz

Who can join

18 and older, any sex, with Colorectal Liver Metastases (CRCLM) or Unresectable Colorectal Liver Metastases. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Monitoring for adverse events related to the procedure.
  Time frame: From 90Y radioembolization (week 2-4) to the end of study at 30 weeks
  Evaluate the safety of combining neoadjuvant ablative dose 90Y radioembolization with standard systemic therapy in patients with CRLM. Safety assessments will include monitoring for adverse events related to the procedure.
• Evaluate the safety related to the procedure by measuring changes in Liver function values in blood.
  Time frame: From 90Y radioembolization (week 2-4) to the end of study at 30 weeks
  To evaluate hepatic safety after neoadjuvant ablative-dose Yttrium-90 radioembolization combined with standard systemic therapy in patients with CRLM changes in laboratory biomarkers will be compared with baseline values and subsequent assessments. Biomarkers and Units of Measure: \- Liver Function Markers: Bilirubin (mg/dL), Albumin (g/dL), Aspartate Aminotransferase (AST) (U/L), Alanine Aminot
• Evaluate the safety related to the procedure by measuring changes in Liver function values in blood.
  Time frame: From 90Y radioembolization (week 2-4) to the end of study at 30 weeks
  To evaluate hepatic safety after neoadjuvant ablative-dose Yttrium-90 radioembolization combined with standard systemic therapy in patients with CRLM changes in laboratory biomarkers will be compared with baseline values and subsequent assessments. Biomarkers and Units of Measure: Inflammatory Marker: C-reactive protein (CRP) (mg/L) Renal Function Marker: Creatinine (mg/dL)
• Evaluate the safety related to the procedure by measuring changes in Liver function values in blood.
  Time frame: From 90Y radioembolization (week 2-4) to the end of study at 30 weeks
  To evaluate hepatic safety after neoadjuvant ablative-dose Yttrium-90 radioembolization combined with standard systemic therapy in patients with CRLM changes in laboratory biomarkers will be compared with baseline values and subsequent assessments. Biomarkers and Units of Measure: Composite Liver Function Scores: Albumin-Bilirubin (ALBI) score (unitless), Albumin-Bilirubin (ALBI) grade (ordinal
• Evaluate the safety related to the procedure by measuring changes in tumor markers in blood.
  Time frame: From 90Y radioembolization (week 2-4) to the end of study at 30 weeks
  Evaluate the safety of combining neoadjuvant ablative dose 90Y radioembolization with standard systemic therapy in patients with CRLM by assessing tumor markers in blood: Carcinoembryonic antigen (CEA) and CA 19-9.
• Evaluate the quality of Life After Liver Resection Assessed by FACT-C (Version 4) Following 90Y Radioembolization
  Time frame: From 90Y radioembolization (week 2-4) to the end of study at 30 weeks
  Evaluate the safety of combining neoadjuvant ablative dose 90Y radioembolization with standard systemic therapy in patients with CRLM. Safety assessments will include assessing overall well-being of the patients focus on quality of life after liver resection. Outcome Measure: Change in Functional Assessment of Cancer Therapy-Colorectal (FACT-C, Version 4) total score from baseline to 30 weeks. Th

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.