Radioactive beads could make liver tumors operable for colorectal cancer patients

NCT ID NCT07406126

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a procedure called Y90 radioembolization, where tiny radioactive beads are injected into the liver to shrink tumors that have spread from colorectal cancer. The goal is to make these tumors removable by surgery in patients who initially cannot have surgery. The study will enroll 30 people and combine the beads with standard chemotherapy, while monitoring safety, tumor shrinkage, and immune response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Yttrium-90 microspheres
What this could lead to
If successful, this approach could help more patients with colorectal liver metastases become eligible for surgery, potentially improving survival and reducing the need for ongoing chemotherapy.
What could go wrong
This is a small, early-phase study with only 30 participants, so results may not apply broadly. The procedure carries risks like liver damage or other side effects, and it may not improve surgical outcomes as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Provincial de Castellón

    Castelló, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, Spain

  • Hospital Universitario de Navarra

    Pamplona, Navarre, Spain

  • Hospital Universitario y Politécnico la Fe

    Valencia, Spain