Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Spain / NCT07406126
Starting soon Observational

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

NCT07406126 · tracked via the Priya Life Science Spain tracker
Sponsor
Fernando Gómez Muñoz
Phase
Observational
Started
2026-02
Last updated
2026-02-12

Condition(s) studied

Colorectal Liver Metastases (CRCLM)Unresectable Colorectal Liver Metastases

Investigational drug(s) / intervention(s)

Yttrium-90 Radioembolization with standard systemic therapy

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Histologically confirmed primary adenocarcinoma of the colon or rectum * Potentially resectable colorectal liver metastases, with limiting factors for resection including: 1. Insufficient future liver remnant. 2. Unfavorable tumor location (e.g. involvement of a major vessel and/or bile duct)/ large size and/ or number of lesions, which limit resection with R0 margins and requires downsizing of the metastases * No or limited extrahepatic metastatic disease (limited extrahepatic disease should be amenable to eradicate with locoregional therapies as per multidisciplinary discussion of surgeons, radiation oncologists and interventional radiologists) * Patient should match standard 90Y radioembolization inclusion criteria: 1. Signed informed consent; 2. Age ≥ 18 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 4. Life expectancy of ≥ 3 months; 5. Measurable target tumors in the liver according to RECIST 1.1 * Laboratory parameters: eGFR \>45/mL/min/1.73 m2; albumin \> 3.0 g/dl, normal bilirubin (unless Gilbert syndrome); aminotransferase (ALAT/ASAT) \<3.0 ULN Exclusion Criteria: * Life expectancy ≤3 months * Patient initially eligible for surgery or thermal ablation of the liver metastases * Progressive extra-hepatic disease * Active extra-hepatic disease that cannot be treated * Life-threatening extra-hepatic disease (i.e. dialysis, unresolved diarrhea, serious unresolved infections (HIV, HBV, HCV etc.)) * Uncorrectable coagulopathy * Contraindication for angiography or MRI * Significant toxicities due to prior cancer therapy that have not resolved before the initiation of the study; if the investigator determines that the continuing complication will compromise the safe treatment of the patient * Any surgical contraindication * Ascites * Expected difficulties for safe execution of TARE based on pretreatment Tc99m-MAA imaging, including; * Flow to extra-hepatic vessels not correctable by reposition of catheter or embolization Uncorrectable estimated dose to the lungs \>30Gy in a single administration or \>50Gy cumulatively * Uncorrectable estimated dose to the untreated liver of \>70Gy * Estimated average dose to the viable tumor volume \<200Gy * Prior liver radiotherapy * Severe portal hypertension * Second primary malignancy within the past 5 years, other that adequately treated non-melanoma skin cancer, carcinoma in situ of any organ or second primary colorectal cancer * Unresectable primary tumor in situ; * Other serious comorbidity or any other condition, that renders patients unsuitable for the study treatment * Pregnancy, lactation or refusal to use adequate contraceptive measures * History of allergic reaction to any components of the treatment that cannot be medically corrected.

Primary outcome measure(s)

  • Monitoring for adverse events related to the procedure. — 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. — 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 Aminotransferase (ALT) (U/L), Gamma-Glutamyl Transferase (GGT) (U/L), Alkaline Phosphatase (FA) (U/L), Cholinesterase (ChE) (U/L), Lactate Dehydrogenase (LDH) (U/L)
  • Evaluate the safety related to the procedure by measuring changes in Liver function values in blood. — 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. — 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 scale)
  • Evaluate the safety related to the procedure by measuring changes in tumor markers in blood. — 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 — 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. The FACT-C (Version 4) total score and each subscale will be analyzed as independent measures to evaluate longitudinal changes in overall well-being and postoperative recovery after liver resection, characterizing treatment-related safety and tolerability. Quality-of-Life Instrument: Functional Assessment of Cancer Therapy-Colorectal (FACT-C, Version 4): Total score and subscale scores (Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Colorectal Cancer Subscale), reported according to standard scoring guidelines.
  • Evaluate the efficacy of the procedure by tumor response rate assessed by means of RECIST 1.1 — From week 0 to resection, progression or week 26-28
    Efficacy assessments will include tumor response rate assessed by means of RECIST 1.1. Baseline efficacy imaging scans will be conducted during the screening phase. Efficacy assessment scans will follow standard-of-care clinical management guidelines, occurring every 8 weeks (with a variance of +/- 1 week) post-inclusion until resection or until progression.
  • Evaluate the efficacy of the procedure: pathologic response assessment on the resected specimens. — From week 0 to resection, progression or week 26-28
    Efficacy assessments will include tumor response rate assessed by means of RECIST 1.1. It will be of capital interest the pathologic response assessment on the resected specimens.

Trial sites (5)

FacilityCityRegionStatus
Hospital Universitario de Navarra Pamplona Navarre
Hospital Provincial de Castellón Castelló Spain
Hospital Universitario Virgen de las Nieves Granada Spain
Hospital Universitario Ramón y Cajal Madrid Spain
Hospital Universitario y Politécnico la Fe Valencia Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07406126 on ClinicalTrials.gov ↗ ← All trials in Spain