NCT07530172

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for phase_2

Timeline
41mo left

Started Dec 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Dec 2025Dec 2029

Study Start

First participant enrolled

December 8, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

March 3, 2026

Last Update Submit

April 8, 2026

Conditions

Heptocellular Cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of re-treatment over 12 months

    Rate of re-treatment of the index lesion over 12 months

    From enrollment to 12 months following the end of treatment

Secondary Outcomes (10)

  • Laboratory toxicities CBC

    From enrollment to 24 months post treatment

  • Laboratory toxicities CMP

    From enrollment to 24 months post treatment

  • Laboratory toxicities INR

    From enrollment to 24 months post treatment

  • Laboratory toxicities AFP

    From enrollment to 24 months post treatment

  • Clinical toxicities

    From enrollment to 24 months post treatment

  • +5 more secondary outcomes

Study Arms (2)

TARE

EXPERIMENTAL

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.

Radiation: Transarterial Radioembolization

SBRT

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Transarterial RadioembolizationRADIATION

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.

TARE
Stereotactic Body Radiation Therapy (SBRT)RADIATION

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.

SBRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Reena Salgia, MD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marissa Gilbert

CONTACT

313-556-8422mgilber6@hfhs.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2026

First Posted

April 15, 2026

Study Start

December 8, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

US(1)