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Y-90 Radioembolization for Colorectal Liver Metastases

This study is testing a treatment called Yttrium-90 (Y-90) resin microspheres for people with colorectal cancer that has spread to the liver (colorectal liver metastases, or CLM). The goal is to see if Y-90 can help control the tumors in the right side of the liver and encourage the left side of the liver to grow larger. This growth, called future liver remnant (FLR) hypertrophy, is important for patients who need surgery to remove liver tumors (hepatectomy) but don't have enough healthy liver tissue. Researchers will look at how safe and practical this treatment is, and how well it helps the liver grow, over about one year. You might be able to join if you are 18 or older, have CLM that can potentially be cured with surgery but don't have enough healthy liver volume, and would normally need another procedure to increase your liver size.

Study design
This is an interventional study planning to enroll 50 participants. It is a prospective study, meaning participants are followed forward in time.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goals of the study will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05195710

Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~50 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Yttrium-90 (Y-90) resin microspheres

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The evaluation from using the feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
Measured over through study completion, an average of 1 year
+1 more outcome measured

Conditions

Metastases

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Ching-Wei Tzeng, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Ching-Wei Tzeng, MD
[email protected]
(713) 792-0386
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • The evaluation from using the feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.through study completion, an average of 1 year
  • The evaluation of using the safety of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.through study completion, an average of 1 year