Ablative Radioembolization for Hepatocellular Carcinoma
Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria
Recruiting
Phase 2Interventional Study
Hepatocellular Carcinoma (HCC)Radioembolization
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Seoul National University Hospital · Other
Who this trial is looking for
This trial is looking for adults with hepatocellular carcinoma (HCC) that is not removable by surgery. Participants will receive a specific treatment using radiation and will be monitored for two years after the procedure.
Are You a Good Fit for This Trial?
You may be able to join if
I am 19 years or older.
I have been diagnosed with hepatocellular carcinoma.
My HCC is not removable by surgery and exceeds the up-to-7 criteria.
All of my tumors are localized in one to five nearby liver sections.
I have no current or previous HCC in my untreated liver.
I have enough healthy liver volume available.
I am in Child-Pugh class A.
I understand the trial and have given my written consent.
You may not be able to join if
I have HCC that has invaded blood vessels or bile ducts.
I have HCC that has spread outside the liver.
I have more than 10 tumors or my largest tumor is smaller than 6 cm.
I am not suitable for the treatment based on blood flow tests.
I have had another active cancer in the last two years.
I have a severe allergy to contrast agents.
I have conditions that prevent me from having certain imaging tests.
I have health issues that could make the treatment unsafe.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
At four major centers in Korea, patients with hepatocellular carcinoma (HCC) that exceed the up-to-7 criteria yet remain locally confined will undergo ablative radioembolization using Yttrium-90 glass microspheres, guided by a standardized dosimetry method. Their treatment response, survival outcomes, and adverse events will be monitored for two years following the procedure.
Trial Locations
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Eligibility Criteria
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: a…
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
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