Radioembolization Versus External Radiation Therapy
Sponsor: Henry Ford Health System
ClinicalTrials ID:NCT07530172
This phase 2 trial compares TARE and SBRT for hepatocellular carcinoma. Eligible participants are adults with ≤3 lesions, Childs-Pugh score ≤8, and ECOG ≤2. TARE involves Yttrium-90 delivery to the tumor, while SBRT is administered over 3-5 fractions. The primary endpoint is the rate of re-treatment of the index lesion over 12 months.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Henry Ford Health System | 48202 | Detroit | Michigan |
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