Recruiting

Phase 2

TARE vs. SBRTRadioembolization Versus External Radiation Therapy

Sponsor:

Henry Ford Health System

Code:

NCT07530172

Conditions

Heptocellular Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transarterial Radioembolization

Stereotactic Body Radiation Therapy (SBRT)

Study Details

Brief summary:

The proposed study is a single site, prospective, randomized phase 2 study to evaluate the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma. The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety. The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue. The primary endpoint is the rate of re-treatment of the index lesion over 12 months.

Conditions

Heptocellular Cancer

Study ID

NCT07530172

Start date

Dec 8, 2025

Status verified date

Apr, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

146 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TARE

The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue.

experimental: SBRT

The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety.

Interventions

Transarterial Radioembolization

Stereotactic Body Radiation Therapy (SBRT)

The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety.

Primary outcome measure

Rate of re-treatment over 12 months [ Time Frame: From enrollment to 12 months following the end of treatment ]

Central Contacts and Locations

Central contacts

Marissa Gilbert

313-556-8422 mgilber6@hfhs.org

Locations

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Marissa Gilbert

3135568422 mgilber6@hfhs.org

More Information

Sponsor

Henry Ford Health System

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-04-15.