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Compares treatment options for Heptocellular Cancer
Official title Radioembolization Versus External Radiation Therapy
ClinicalTrials.gov ID: NCT07530172
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.