Can radiation beads shrink untreatable liver tumors?
NCT ID NCT06773845
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This trial tests a targeted radiation therapy for people with large, localized liver cancer that cannot be surgically removed. Tiny glass beads carrying Yttrium-90 are injected into the liver's blood vessels to deliver a high dose of radiation directly to tumors. Researchers will track how well the tumors shrink and how long patients live over two years, while also monitoring side effects.
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) delivered via radioembolization
- What this could lead to
- If successful, this approach could offer a new way to control large liver tumors that are currently hard to treat, potentially improving survival and quality of life.
- What could go wrong
- This is a phase 2 trial, so results are preliminary. High-dose radiation may cause liver damage or other side effects, and not all tumors may respond as hoped.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2025
- Expected to finish
-
Dec 2030
An estimate. End dates often move.
- Lead sponsor
-
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
-
19 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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 * Adult aged 19 and over * HCC diagnosed by histology or non-invasive criteria of the American Association for the Study of Liver Disease * Unresectable HCC beyond the UT7 criteria: the sum of the diameter of the largest tumor (cm) and the number of tumors \> 7 * Localized HCC: all tumors are in the one to five geographically adjacent Couinaud segments * No current or previous HCC in the untreated liver (i.e., future liver remnant \[FLR\]) * FLR volume \> 30% of total non-tumorous liver volume * Child-Pugh class A * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * No major organ dysfunction according to blood test performed within two months of study enrollment: * Leukocytes ≥ 2,000/µL and ≤ 15,000/µL * Hemoglobin ≥ 8.0 g/dL (transfusion allowed to meet this criterion) * Total bilirubin ≤ 2.0 mg/dL * Platelet ≥ 40,000/µL * International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants * Aspartate transaminase (AST) ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) * Alanine transaminase (ALT) ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) * Creatinine ≤ 2.5 mg/dL * Patients with a life expectancy of more than 3 months * For women of childbearing age, a negative serum pregnancy test * Patients who have adequately understood the clinical trial and consented in writing Exclusion Criteria: * HCC with vascular invasion and/or bile duct invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI) * HCC with extrahepatic spread on chest CT and abdominal CT or MRI * Multinodular disseminated HCC: largest tumor size \< 6 cm, or number of tumors \> 10 * Patients who are not suitable for ablative radioembolization as indicated by pre-treatment mapping with 99mTc-macroaggregated albumin (MAA): * Cases where the estimated lung dose exceeds 30 Gy when 350 Gy of tumor absorbed dose is administered to the tumor based on the multicompartment Medical Internal Radiation Dose (MIRD) model * Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments * Cases where the operator determines that there is substantial adhesion with the surrounding organs such as the bowel, making ablative radioembolization infeasible * Cases where the operator judges that the occurrence of even mild radiation pneumonitis could be fatal, based on marked emphysema or interstitial lung disease findings on chest CT * Patients who have had active cancer within the last two years prior to the study enrollment * History of severe allergy of intolerance to contrast agents * Contraindication to angiography or selective visceral catheterization
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hepatocellular carcinoma (HCC) are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
8 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Gangneung Asan Hospital
RECRUITINGGangneung, Gangwon-do, 25440, South Korea
-
Hallym University Sacred Heart Hospital
RECRUITINGAnyang-si, Gyeonggi-do, 14068, South Korea
-
National Cancer Center
RECRUITINGIlsan, Gyeonggi-do, 10408, South Korea
-
Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
-
Seoul Asan Hospital
NOT_YET_RECRUITINGSeoul, 05505, South Korea
-
Seoul National University Bundang Hospital
RECRUITINGSeongnam-si, Gyeonggi-do, 13620, South Korea
-
Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
-
Severance Hospital
RECRUITINGSeoul, 03722, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new PET tracer spot liver cancer more clearly?
- Can a smart drug starve liver tumors without harming healthy tissue?
- Liver size may hold key to immunotherapy response
- Can a new model forecast liver cancer in hepatitis b?
- Can an Anti-Inflammatory drug make liver cancer immunotherapy safer?
- Can a Two-Drug combo outsmart advanced liver cancer?