Colorectal Liver Metastases (CRCLM)YRENENCT07406126
Yttrium-90 Radioembolization Neoadjuvant Therapy With Immune Marker Profiling and Dosimetry for Potentially Resectable Patients With Colorectal Liver Metastases
An observational study of Colorectal Liver Metastases (CRCLM) and Unresectable Colorectal Liver Metastases, run by Fernando Gómez Muñoz at 5 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Liver Metastases (CRCLM), Unresectable Colorectal Liver Metastases
- What is being tested?
- Yttrium-90 Radioembolization with standard systemic therapy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 5 sitesSpain
- Study dates
- Feb 2026to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (N = 30) with insufficient FLR and patients with unfavorable lesion location, size and/ or number, requiring downsizing of metastases in order to achieve R0 resection will be discussed at the respective local multidisciplinary teams (MDT) meetings. Patients can be included if they are found suitable for TARE and surgery based on a liver MRI, contrast enhanced CT or PET-CT and clinical and laboratory results. Patients are allowed to undergo other local liver treatments (e.g. ablation) in combination with TARE, as long as all liver metastasis are locally treated to achieve R0 resection. Patients are not allowed to use systemic chemotherapy two weeks prior and two weeks post TARE. Target therapies have to be stopped at least 4 weeks prior to TARE.
Who may be able to join
- Histologically confirmed primary adenocarcinoma of the colon or rectum
- Potentially resectable colorectal liver metastases, with limiting factors for resection including:
- Insufficient future liver remnant.
- 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:
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- Signed informed consent;
- Age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Life expectancy of ≥ 3 months;
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites
Hospital Provincial de Castellón
Castelló
Jorge Molina, MD, jorgemolinasaera@gmail.com
Jorge Molina, MD
Hospital Universitario Virgen de las Nieves
Granada
Antonio Rodriguez, MD PhD, antonio.rodriguez.fernandez.sspa@juntadeandalucia.es
Antonio Rodríguez, MD PhD
Hospital Universitario Ramón y Cajal
Madrid
José Urbano
jurbano@salud.madrid.org
Hospital Universitario de Navarra
Pamplona, Navarre
Iñigo Insausti, inigo.insausti.gorbea@navarra.es
Iñigo Insausti
Hospital Universitario y Politécnico la Fe
Valencia
Fernando Gómez, MD PhD, gomez_fermun@gva.es
Fernando Gómez, MD PhD
About this study
Official title: 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
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.
- Being tested
- Yttrium-90 Radioembolization with standard systemic therapy
- Keywords
- Unresectable Colorectal Liver Metastases, Potentially resectable patient, neoadjuvant therapy, Immune Marker Profiling, circulating tumor DNA, personalized dosimetry approach, Insufficient future liver remnant, Observational, multicenter, prospective, YRENE, TARE, TheraSphere®, Yttrium-90, Transarterial Radioembolization, primary colon adenocarcinoma, primary rectum adenocarcinoma, Unfavourable tumor location, metastatic disease, FOLFOX 6
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium-90 Radioembolization with standard systemic therapyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring for adverse events related to the procedure.
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.
Measured: From 90Y radioembolization (week 2-4) to the end of study at 30 weeks
Evaluate the safety related to the procedure by measuring changes in Liver function values in blood.
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)
Measured: From 90Y radioembolization (week 2-4) to the end of study at 30 weeks
Evaluate the safety related to the procedure by measuring changes in Liver function values in blood.
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)
Measured: From 90Y radioembolization (week 2-4) to the end of study at 30 weeks
Evaluate the safety related to the procedure by measuring changes in Liver function values in blood.
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)
Measured: From 90Y radioembolization (week 2-4) to the end of study at 30 weeks
Evaluate the safety related to the procedure by measuring changes in tumor markers in blood.
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.
Measured: From 90Y radioembolization (week 2-4) to the end of study at 30 weeks
Evaluate the quality of Life After Liver Resection Assessed by FACT-C (Version 4) Following 90Y Radioembolization
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.
Measured: From 90Y radioembolization (week 2-4) to the end of study at 30 weeks
Evaluate the efficacy of the procedure by tumor response rate assessed by means of RECIST 1.1
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.
Measured: From week 0 to resection, progression or week 26-28
Evaluate the efficacy of the procedure: pathologic response assessment on the resected specimens.
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.
Measured: From week 0 to resection, progression or week 26-28
Secondary outcomes (9)
Resection rate in patients undergoing the combined approach
It will indicate the percentage of patients who ultimately proceed to surgical resection of their liver metastases after receiving TARE as part of the neoadjuvant therapy. The decision of resection will be taken in the respective multidisciplinary meetings of each participating center.
Measured: week 18-20 and week 26-28
Cellular population quantification on peripheral blood samples: leukocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.
Microbial fuel cell procedure will be performed on peripheral blood samples within the first 24-36 hours after collection. Bulk lysis technique will be done with the aim to concentrate leukocytes and, later, to detect minority populations. The quantification of each population will be performed in percentage and in absolute count, estimating the cells per microliter from the leukocyte value obtained in the complete blood count (CBC). In fact, a CBC will be done obtaining the percentages and absolutes values of neutrophils, lymphocytes, monocytes, eosinophils and basophils. Neutrophil-to-lymphocyte and lymphocyte-to-monocyte ratios will be estimated.
Measured: Week 0, 6, 8 and 16
Inflammatory interleukines IL-6, IL-10 and IFN-γ quantification:
Cytokines IL6 and IL10 levels
Measured: Week 0, 6, 8 and 16
Intratumoral T Cells Infiltration in biopsies and resected tumors.
The density of each tumor-infiltrating immune cell (CD3 and CD8) will be assessed in biopsies and resected tumors.
Measured: week 0, week 18/20 and week 26/28
PERSONALIZED AI ASSISTED DOSIMETRY evaluation
AI assisted dosimetry will be evaluated by the creation of a predictive model to assess treatment outcome based on planned and post-treatment high precision dose estimates. A prediction model based on corrected planning SPECT/CT and post-treatment PET/CT.
Measured: week 0 to 26-28
ctDNA analysis: Identification of genetic alterations and circulating tumor DNA (ctDNA) monitoring through digital droplet PCR
Sample collection and Nucleic acid isolation will be performed by means of Formalin-fixed paraffin embedded (FFPE) tumor biopsies (metastases). Two 10 mL Cell-Free DNA BCT ® CE (Streck) tubes of peripheral blood will be extracted for liquid biopsy studies. In FFPE tumour by NGS colorectal cancer cells are characterized by the acquisition of molecular alterations responsible for tumor development and progression. Digital droplet PCR (ddPCR) has emerged as an ultra-sensitive approach with various applications in the molecular diagnosis of tumors especially in liquid biopsy studies. KRAS, NRAS and BRAF mutation detection will be carried out.
Measured: week 6, 8, 12, 16, 22 and 30
Macroscopic determination of the grade of necrosis
the grade of necrosis will be analyzed through Histochemical staining of histological samples: standard hematoxylin-eosin staining. Staining of non-tumor liver with at least: Masson's trichrome and reticulin.
Measured: week 18/20 and week 26/28.
Determination of the grade of necrosis: Microscopic study.
The Microscopic report will include the number of nodules, size, distance to margin in mm, tumor regression grade and the lesions observed in the non-tumor liver parenchyma in resected tumors. With the presence or absence of viable tumor cells, it is advisable to report on the presence or absence of: Fibrosis, Necrosis, specifying whether it is of the normal or infarct-type and mucous extracellular.
Measured: week 18/20 and week 26/28.
Evaluation of Post-treatment liver damage: Microscopic study
Post-treatment liver damage: Presence and severity of steatosis, steatohepatitis and lesions related to the sinusoidal obstruction syndrome will be reported.
Measured: week 18/20 and week 26/28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal Liver Metastases (CRCLM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fernando Gómez Muñoz
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe, Boston Scientific International S.A.
- Responsible party
- Sponsor-investigator, Fernando Gómez Muñoz, Instituto de Investigacion Sanitaria La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406126
- Sponsor's protocol ID
- GIBI2^30- YRENE
- Acronym
- YRENE
- Status last verified
- Feb 2026
- First submitted
- 4 Dec 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be shared with qualified researchers upon reasonable request. Data will be available after publication for a period of 5 years. Requests should be directed to GIBI230@iislafe.es. Access will be provided after approval of a proposal and execution of a data use agreement.
Publications
Alsultan AA, van Roekel C, Barentsz MW, Smits MLJ, Kunnen B, Koopman M, Braat AJAT, Bruijnen RCG, de Keizer B, Lam MGEH. Dose-Response and Dose-Toxicity Relationships for Glass 90Y Radioembolization in Patients with Liver Metastases from Colorectal Cancer. J Nucl Med. 2021 Nov;62(11):1616-1623. doi: 10.2967/jnumed.120.255745. Epub 2021 Mar 19.
PubMed 33741643Mulcahy MF, Mahvash A, Pracht M, Montazeri AH, Bandula S, Martin RCG 2nd, Herrmann K, Brown E, Zuckerman D, Wilson G, Kim TY, Weaver A, Ross P, Harris WP, Graham J, Mills J, Yubero Esteban A, Johnson MS, Sofocleous CT, Padia SA, Lewandowski RJ, Garin E, Sinclair P, Salem R; EPOCH Investigators. Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial. J Clin Oncol. 2021 Dec 10;39(35):3897-3907. doi: 10.1200/JCO.21.01839. Epub 2021 Sep 20.
PubMed 34541864Torkian P, Haghshomar M, Farsad K, Wallace S, Golzarian J, Young SJ. Cancer Immunology: Impact of Radioembolization of Hepatocellular Carcinoma on Immune Response Modulation. AJR Am J Roentgenol. 2023 Jun;220(6):863-872. doi: 10.2214/AJR.22.28800. Epub 2023 Feb 8.
PubMed 36752368Garin E, Tselikas L, Guiu B, Chalaye J, Edeline J, de Baere T, Assenat E, Tacher V, Robert C, Terroir-Cassou-Mounat M, Mariano-Goulart D, Amaddeo G, Palard X, Hollebecque A, Kafrouni M, Regnault H, Boudjema K, Grimaldi S, Fourcade M, Kobeiter H, Vibert E, Le Sourd S, Piron L, Sommacale D, Laffont S, Campillo-Gimenez B, Rolland Y; DOSISPHERE-01 Study Group. Personalised versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial. Lancet Gastroenterol Hepatol. 2021 Jan;6(1):17-29. doi: 10.1016/S2468-1253(20)30290-9. Epub 2020 Nov 7.
PubMed 33166497Simmonds PC, Primrose JN, Colquitt JL, Garden OJ, Poston GJ, Rees M. Surgical resection of hepatic metastases from colorectal cancer: a systematic review of published studies. Br J Cancer. 2006 Apr 10;94(7):982-99. doi: 10.1038/sj.bjc.6603033.
PubMed 16538219De Greef K, Rolfo C, Russo A, Chapelle T, Bronte G, Passiglia F, Coelho A, Papadimitriou K, Peeters M. Multisciplinary management of patients with liver metastasis from colorectal cancer. World J Gastroenterol. 2016 Aug 28;22(32):7215-25. doi: 10.3748/wjg.v22.i32.7215.
PubMed 27621569
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07406126
- Acronym / sponsor ID
- YRENE / GIBI2^30- YRENE
- Keywords
- Unresectable Colorectal Liver Metastases, Potentially resectable patient, neoadjuvant therapy, Immune Marker Profiling, circulating tumor DNA, personalized dosimetry approach, Insufficient future liver remnant, Observational
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fernando Gómez MuñozUniversity, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe, Boston Scientific International S.A.
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (N = 30) with insufficient FLR and patients with unfavorable lesion location, size and/ or number, requiring downsizing of metastases in order to achieve R0 resection will be discussed at the respective local multidisciplinary teams (MDT) meetings. Patients can be included if they are found suitable for TARE and surgery based on a liver MRI, contrast enhanced CT or PET-CT and clinical and laboratory results. Patients are allowed to undergo other local liver treatments (e.g. ablation) in combination with TARE, as long as all liver metastasis are locally treated to achieve R0 resection. Patients are not allowed to use systemic chemotherapy two weeks prior and two weeks post TARE. Target therapies have to be stopped at least 4 weeks prior to TARE.
Key inclusion criteria (12 listed)
- Histologically confirmed primary adenocarcinoma of the colon or rectum
- Potentially resectable colorectal liver metastases, with limiting factors for resection including:
- 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:
- 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
Key exclusion criteria (21 listed)
- 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.))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yttrium-90 Radioembolization with standard systemic therapyYttrium-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. | Procedure or surgery | – |
Primary outcome
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 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.
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 scale)
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. 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
Time frame: 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.
Time frame: 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.
9 secondary outcomes
Resection rate in patients undergoing the combined approach
Time frame: week 18-20 and week 26-28
Cellular population quantification on peripheral blood samples: leukocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.
Time frame: Week 0, 6, 8 and 16
Inflammatory interleukines IL-6, IL-10 and IFN-γ quantification:
Time frame: Week 0, 6, 8 and 16
Intratumoral T Cells Infiltration in biopsies and resected tumors.
Time frame: week 0, week 18/20 and week 26/28
PERSONALIZED AI ASSISTED DOSIMETRY evaluation
Time frame: week 0 to 26-28
ctDNA analysis: Identification of genetic alterations and circulating tumor DNA (ctDNA) monitoring through digital droplet PCR
Time frame: week 6, 8, 12, 16, 22 and 30
Macroscopic determination of the grade of necrosis
Time frame: week 18/20 and week 26/28.
Determination of the grade of necrosis: Microscopic study.
Time frame: week 18/20 and week 26/28.
Evaluation of Post-treatment liver damage: Microscopic study
Time frame: week 18/20 and week 26/28.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 33741643Alsultan AA, van Roekel C, Barentsz MW, Smits MLJ, Kunnen B, Koopman M, Braat AJAT, Bruijnen RCG, de Keizer B, Lam MGEH. Dose-Response and Dose-Toxicity Relationships for Glass 90Y Radioembolization in Patients with Liver Metastases from Colorectal Cancer. J Nucl Med. 2021 Nov;62(11):1616-1623. doi: 10.2967/jnumed.120.255745. Epub 2021 Mar 19.
- Background: PubMed 34541864Mulcahy MF, Mahvash A, Pracht M, Montazeri AH, Bandula S, Martin RCG 2nd, Herrmann K, Brown E, Zuckerman D, Wilson G, Kim TY, Weaver A, Ross P, Harris WP, Graham J, Mills J, Yubero Esteban A, Johnson MS, Sofocleous CT, Padia SA, Lewandowski RJ, Garin E, Sinclair P, Salem R; EPOCH Investigators. Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial. J Clin Oncol. 2021 Dec 10;39(35):3897-3907. doi: 10.1200/JCO.21.01839. Epub 2021 Sep 20.
- Background: PubMed 36752368Torkian P, Haghshomar M, Farsad K, Wallace S, Golzarian J, Young SJ. Cancer Immunology: Impact of Radioembolization of Hepatocellular Carcinoma on Immune Response Modulation. AJR Am J Roentgenol. 2023 Jun;220(6):863-872. doi: 10.2214/AJR.22.28800. Epub 2023 Feb 8.
- Background: PubMed 33166497Garin E, Tselikas L, Guiu B, Chalaye J, Edeline J, de Baere T, Assenat E, Tacher V, Robert C, Terroir-Cassou-Mounat M, Mariano-Goulart D, Amaddeo G, Palard X, Hollebecque A, Kafrouni M, Regnault H, Boudjema K, Grimaldi S, Fourcade M, Kobeiter H, Vibert E, Le Sourd S, Piron L, Sommacale D, Laffont S, Campillo-Gimenez B, Rolland Y; DOSISPHERE-01 Study Group. Personalised versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial. Lancet Gastroenterol Hepatol. 2021 Jan;6(1):17-29. doi: 10.1016/S2468-1253(20)30290-9. Epub 2020 Nov 7.
- Background: PubMed 16538219Simmonds PC, Primrose JN, Colquitt JL, Garden OJ, Poston GJ, Rees M. Surgical resection of hepatic metastases from colorectal cancer: a systematic review of published studies. Br J Cancer. 2006 Apr 10;94(7):982-99. doi: 10.1038/sj.bjc.6603033.
- Background: PubMed 27621569De Greef K, Rolfo C, Russo A, Chapelle T, Bronte G, Passiglia F, Coelho A, Papadimitriou K, Peeters M. Multisciplinary management of patients with liver metastasis from colorectal cancer. World J Gastroenterol. 2016 Aug 28;22(32):7215-25. doi: 10.3748/wjg.v22.i32.7215.
- American Cancer Society. Key Statistics for Colorectal Cancer.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be shared with qualified researchers upon reasonable request. Data will be available after publication for a period of 5 years. Requests should be directed to GIBI230@iislafe.es. Access will be provided after approval of a proposal and execution of a data use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Liver Metastases (CRCLM) and Unresectable Colorectal Liver Metastases, run by Fernando Gómez Muñoz at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando Gómez, MD PhD (+34 628281300, gomez_fermun@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring for adverse events related to the procedure. (time frame: From 90Y radioembolization (week 2-4) to the end of study at 30 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07406126, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.