Can a One-Time radiation bead treatment extend life in advanced liver cancer?
NCT ID NCT06166576
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This trial is testing a procedure called ablative radioembolization, which delivers tiny radioactive beads (Yttrium-90) directly to liver tumors. It is for adults with hepatocellular carcinoma that has spread into the portal vein but is still confined to one lobe of the liver. The goal is to see if this high-dose radiation approach can improve overall survival and shrink tumors in people who maintain good liver function.
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) given via ablative radioembolization
- What this could lead to
- If successful, this could offer a more effective way to treat liver cancer that has spread into nearby blood vessels, potentially extending survival.
- What could go wrong
- This is a small, early-phase study, so results may not apply broadly. The high radiation dose could damage healthy liver tissue or cause side effects.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Nov 2027
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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18 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. Adults aged 18 and over 2. Patients diagnosed with unilobar hepatocellular carcinoma, either histologically and/or radiologically (LI-RADS 4 or 5) 3. Patients with at least one measurable lesion greater than 10 mm on dynamic contrast-enhanced CT or MRI 4. Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamic contrast-enhanced CT or MRI 5. Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominal CT or MRI 6. Patients with no prior treatment for liver cancer 7. Child-Pugh class A 8. Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less 9. Patients without serious dysfunction of major organs, as indicated by blood tests conducted within one month of study enrollment 1. Leukocytes ≥ 2,500/µL and ≤ 12,000/µL 2. Absolute neutrophil count ≥ 1,500/mm\^3 3. Hemoglobin ≥ 8.0 g/dL (transfusions allowed to meet this criterion) 4. Total bilirubin ≤ 3.0 mg/dL 5. Platelets ≥ 50,000/µL 6. For patients not on anticoagulants, INR ≤ 2.0 7. AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) 8. ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) 9. ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit) 10. Creatinine ≤ 2.0 mg/dL 10. Patients with a life expectancy of more than 3 months 11. Patients who have fully understood the clinical trial and given written consent 12. Female patients of childbearing age confirmed not to be pregnant Exclusion Criteria: 1. Patients unsuitable for ablative radioembolization as per the pre-test with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization. 1. Cases where, according to multi-compartment Medical Internal Radiation Dose method, delivering 205 Gy of radiation to the tumor exceeds an estimated lung dose of 25 Gy. 2. Cases with severe hepatic artery-portal vein shunting leading to expected irradiation of the non-tumorous opposite lobe. 2. Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume. 3. Patients with hepatic vein or bile duct invasion as seen on dynamic contrast-enhanced CT or MRI. 4. Patients scheduled to use immunotherapy regardless of the response to radioembolization. 5. Patients who had active cancer within two years prior to joining the clinical trial. 6. Patients who have undergone surgery or procedures related to the bile duct. 7. Pregnant or breastfeeding women.
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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
5 sites. 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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National Cancer Center
RECRUITINGIlsan, Gyeonggi-do, 10408, South Korea
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Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
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Seoul National University Bundang Hospital
RECRUITINGSeongnam-si, Gyeonggi-do, 13620, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, Seoul, 03080, South Korea
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Severance Hospital
RECRUITINGSeoul, 03722, South Korea
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Other studies related to the condition(s) this trial covers.
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- Can turbocharged immune cells stop liver cancer from coming back?
- Two blood markers put to the test for early liver cancer detection
- New antibody pair takes aim at advanced liver cancer in major trial
- New antibody aims to preserve immune checkpoint while fighting cancer