Radioactive beads take aim at inoperable liver tumors
NCT ID NCT07110233
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests a treatment called Yttrium-90 radiation segmentectomy for people with liver cancer that can't be removed by surgery. Tiny radioactive beads are injected into the blood supply of the tumor to deliver targeted radiation. The study will enroll 64 participants to see if the treatment shrinks tumors and how safe it is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Yttrium-90 glass microspheres (TheraSphere)
- What this could lead to
- If successful, this could offer a new, less invasive option to control liver tumors that can't be surgically removed, potentially allowing some patients to later receive a transplant.
- What could go wrong
- This is an early phase 2 trial with only 64 participants, so results may not apply to everyone. There is a risk of side effects like liver damage or radiation-related issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants must have histologically or imaging-confirmed confirmed HCC. 2. Group 1: Solitary tumor measuring 2-5 cm Or Group 2: 2-3 tumors each ≤ 3 cm in diameter. 3. No prior therapy to target tumor(s). 4. Not a candidate for surgical resection or thermal ablation after multidisciplinary assessment. 5. Age ≥22 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status = 0 or 1. 7. Demonstrated adequate organ function as defined below: 1. Total bilirubin ≤3.0 mg/dL, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits. 2. aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤5 X institutional upper limit of normal. 3. alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤5 X institutional upper limit of normal. 4. Creatinine Glomerular filtration rate (GFR) \> 30 ml/min. 8. Child-Pugh score ≤ B7 9. Albumin-bilirubin (ALBI) score 1-2 10. Participants who have received systemic therapy for HCC will be excluded from the trial. 11. Ability to understand a written informed consent document, and the willingness to sign it. 12. Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. 13. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Exclusion Criteria: 1. Macrovascular tumor invasion or infiltrative appearance of hepatocellular carcinoma. 2. History of severe allergy to iodinated contrast agents despite appropriate premedication. 3. Is currently receiving any other anti-cancer agents and any previous therapy with a device that uses Y90 as the radioisotope. 4. Symptomatic heart failure or severe valvular insufficiency. 5. Symptomatic pulmonary hypertension or lung disease. 6. Symptomatic ascites. 7. Severe uncontrolled coagulopathy International Normalized Ratio (INR) ≥ 3.0 or Platelet ≤ 20,000. 8. Main vein thrombosis (portal vein, both bland and tumor thrombus). Note: Less than lobar portal vein thrombosis is allowable only if the thrombus is bland. 9. Pregnant women are excluded from this study because TheraSphere emits radiation with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TheraSphere, breastfeeding should be discontinued if the mother is treated with TheraSphere. 10. Lung-shunt fraction (LSF) resulting in anticipated lung dose of \>30 Gray (Gy). 11. History of sphincterotomy, biliary-enteric anastomosis, or other biliary tract instrumentation. Note: Prior cholecystectomy with or without bile duct exploration is permitted. 12. Tumor perfused by extrahepatic collateral arteries. 13. Prior partial hepatectomy. 14. Psychiatric illness, other significant medical illness, or social situation which, in the investigator's opinion, would limit compliance or ability to comply with study requirements. 15. History of or current extrahepatic cancer. 16. Pulmonary insufficiency (defined by an arterial oxygen pressure (Pa,O2) of \< 60 mmHg, or oxygen saturation (Sa,O2) of \< 90%).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of California, San Francisco
San Francisco, California, 94143, United States
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