Actively Recruiting
Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria
Led by Seoul National University Hospital · Updated on 2025-06-17
100
Participants Needed
4
Research Sites
250 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years and older
- Diagnosis of hepatocellular carcinoma by histology or non-invasive criteria
- Unresectable HCC beyond the up-to-seven criteria (sum of largest tumor diameter and number of tumors greater than 7)
- Tumors localized to one to five geographically adjacent Couinaud liver segments
- No current or previous HCC in the untreated future liver remnant
- Future liver remnant volume greater than 30% of non-tumorous liver volume
- Child-Pugh class A liver function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No major organ dysfunction based on blood tests within two months before enrollment:
- Leukocytes between 2,000/µL and 15,000/µL
- Hemoglobin at least 8.0 g/dL (transfusion allowed)
- Total bilirubin 2.0 mg/dL or less
- Platelets at least 40,000/µL
- INR 2.0 or less for patients not on anticoagulants
- AST 200 IU/L or less
- ALT 200 IU/L or less
- Creatinine 2.5 mg/dL or less
- Life expectancy longer than 3 months
- Negative pregnancy test for women of childbearing age
- Written informed consent after understanding the clinical trial
You will not qualify if you...
- HCC with vascular or bile duct invasion seen on imaging
- HCC spread outside the liver on chest or abdominal CT or MRI
- Multinodular disseminated HCC with the largest tumor under 6 cm or more than 10 tumors
- Unsuitability for ablative radioembolization based on 99mTc-MAA mapping including:
- Estimated lung dose over 30 Gy when tumor dose is 350 Gy
- Severe hepatic artery-portal vein shunting risking non-tumorous liver irradiation
- Substantial adhesion to surrounding organs preventing safe treatment
- High risk of fatal radiation pneumonitis due to severe emphysema or interstitial lung disease
- Active cancer within 2 years before enrollment
- Severe allergy or intolerance to contrast agents
- Contraindications to angiography or selective catheterization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
National Cancer Center
Ilsan, Gyeonggi-do, South Korea, 10408
Actively Recruiting
2
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
3
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
4
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
H
Hyun Hee Lee
CONTACT
M
Mina Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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