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New hope for liver metastases: Y-90 radiation before surgery may boost candidacy

NCT ID NCT05195710

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 1 trial is testing whether injecting tiny radioactive beads (Y-90) into the right side of the liver can shrink tumors and make the left side grow larger, so more patients with colorectal cancer liver metastases can have potentially curative surgery. The study will enroll 50 patients whose liver is too small for safe surgery. Researchers are primarily checking if the procedure is safe and feasible.

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 (Y-90) resin microspheres
What this could lead to
If successful, this approach could make more patients eligible for curative liver surgery by shrinking tumors and growing healthy liver tissue.
What could go wrong
This is an early phase 1 trial with only 50 participants, so safety and feasibility are still being tested. The procedure may not work for everyone and carries risks like radiation damage to healthy tissue.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 50 people

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

Started

Nov 2022

Expected to finish

Mar 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.

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: * Borderline resectable unresectable (due to insufficient liver volume at presentation) colorectal liver metastases with potential curative intent, as determined by the surgeon and multidisciplinary team * Anticipated standardized FLR (sFLR) that would require right portal vein embolization (PVE) to increase the sFLR prior to either a single major hepatectomy, or prior to the second stage hepatectomy as part of a two-stage hepatectomy strategy, all in the setting of curative-intent resection(s). This evaluation will be documented in the clinical chart * Received at least four cycles (or two months) of chemotherapy * Willing, able and mentally competent to provide written informed consent * Medically and physically operable as determined by the surgeon Exclusion Criteria: * Extrahepatic disease that precludes intended curative intent treatment sequencing (treatable primary tumor and lung metastases allowed). "Treatable" is defined as having an intended future plan for local therapy (surgery, radiation, or ablation) as determined by the patient's medical oncologist and surgical oncologist * Projected sFLR before Y-90 of \<20% (starting with sFLR that is unrealistic for improvement to ≥30%) * Performance status limitations (Karnofsky \<80%, ECOG \>1) * Portal hypertension and/or cirrhosis * Starting total bilirubin \>1.3 mg/dL (except if patient has Gilbert's Disease) * CEA \>200 after 4 cycles of chemotherapy upon restaging visit * Clinical progression of disease on imaging and/or tumor marker after 4 cycles of chemotherapy that is clinically judged by surgical oncology and medical oncology to preclude surgical resection * Platelet count \<100,000/µL * Albumin \<3.5 g/dl * Symptomatic primary colon or rectal cancer (without pre-existing proximal diverting ostomy) * Pregnant or breast-feeding patient * Other medical or clinical contraindications to liver surgery * Non-English-speaking participants

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Conditions

The condition(s) this trial relates to.

metastatic neoplasm 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

    1 site. 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

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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