Clinical trial · Interventional
Radioembolization Versus External Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Heptocellular Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | — | UNRESOLVED |
| Transarterial Radioembolization | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TARE
- description
- 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.
- interventionNames
- Radiation: Transarterial Radioembolization
- type
- EXPERIMENTAL
- label
- SBRT
- description
- 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.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available