Comparing targeted Y-90 radioembolization with focused external SBRT for liver cancer

Radioembolization Versus External Radiation Therapy

This trial tests whether Y-90 transarterial radioembolization or focused stereotactic body radiation (SBRT) better controls hepatocellular carcinoma lesions in adults eligible for either treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Henry Ford Health System (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT07530172 on ClinicalTrials.gov

What this trial studies

This single-site, randomized phase 2 trial at Henry Ford Health System compares transarterial radioembolization (TARE) using selective Yttrium-90 delivery to stereotactic body radiation therapy (SBRT) delivered in 3–5 fractions. Patients with up to three HCC lesions who meet liver function and performance status criteria are randomized to either a planning arteriogram with segmental Y-90 infusion (dose prescribed to deliver ≥200 Gy to perfused tissue) or standard SBRT with dose adjusted for safety. The primary endpoint is the rate of re-treatment of the index lesion within 12 months, with safety and tolerability monitored throughout. Key eligibility limits include Child-Pugh score ≤8, ECOG ≤2, no macrovascular invasion, and no prior SBRT or radioembolization to the target.

Who should consider this trial

Good fit: Adults (≥18) with up to three hepatocellular carcinoma lesions considered suitable for either TARE or SBRT, Child-Pugh ≤8, ECOG ≤2, and adequate liver function (bilirubin <4.0 mg/dL, albumin >2 g/dL) are ideal candidates.

Not a fit: Patients with macrovascular invasion, prior SBRT or radioembolization to the target lesion, planned systemic consolidation therapy, pregnancy/lactation, or severe contrast allergy/coagulopathy are excluded and unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, the trial could identify the approach that reduces the need for repeat procedures and improves local control of liver tumors with acceptable safety.

How similar studies have performed: Both Y-90 radioembolization and SBRT have shown local control in prior single-arm and comparative studies, but randomized head-to-head data are limited, so this direct comparison is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Ability to provide written informed consent and HIPAA authorization
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥ 18 years at time of informed consent
* No more than 3 lesions of HCC evaluated to be eligible for TARE or SBRT at multidisciplinary tumor board
* Childs-Pugh score ≤ 8
* ECOG performance status ≤2
* Adequate organ function defined as:
* serum bilirubin \< 4.0 mg/dL ,
* albumin \> 2 g/dL

Exclusion Criteria:

* Any prior SBRT or radioembolization to the target tumor
* Macrovascular invasion
* Planned or recommended systemic therapy as consolidation
* Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration.
* Known severe allergic reaction (anaphylaxis) to iodinated contrast Coagulopathy that the provider deems would be unsafe for transarterial therapy

Where this trial is running

Detroit, Michigan

• Henry Ford Health System — Detroit, Michigan, United States (Recruiting)

Study contacts

• Principal investigator: Reena Salgia, MD — Henry Ford Health System
• Study coordinator: Marissa Gilbert

Conditions Heptocellular Cancer