A Prospective Observational Study on Efficacy of TARE for Early Stage HCC (KURE-YTT-HCC)

November 29, 2025 updated by: Yoon Jun Kim, Seoul National University Hospital

A Korean Multicenter Prospective Observational Study on Efficacy of 90Y for Hepatocellular Carcinoma-early Stage

The aim of the current study is to analyze treatment outcomes (best target lesion response, overall survival, time to target lesion progression, time to overall progression, and treatment-related adverse event) using prospectively collected clinical and imaging data in patients with BCLC 0 or A HCCs treated with TheraSphere® in four large-volume hospitals from Korea. The results will pave the way for expanding 90Y-TARE indication and refining reimbursement guidelines, and provide baseline data for possible subsequent future studies.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients receiving TARE using TheraSphere® Treatment naïve BCLC 0 or A single HCC up to 8 cm (diagnosed according to diagnostic criteria of KLCA-NCC) Tumor involvement < 50% of total liver volume based on dynamic CT or MRI Age > or = 18 ECOG performance status 0 AST/ALT < or = 5 times the upper limits of normal A life expectancy > 3 months Non-pregnant with an acceptable contraception in premenopausal women Ability to provide written informed consent and to comply with all study conditions

Description

Inclusion Criteria:

  • A. Patients receiving TARE using TheraSphere® B. Treatment naïve BCLC 0 or A single HCC up to 8 cm (diagnosed according to diagnostic criteria of KLCA-NCC) C. Tumor involvement < 50% of total liver volume based on dynamic CT or MRI D. Age > or = 18 E. ECOG performance status 0 F. AST/ALT < or = 5 times the upper limits of normal G. A life expectancy > 3 months H. Non-pregnant with an acceptable contraception in premenopausal women I. Ability to provide written informed consent and to comply with all study conditions

Exclusion Criteria:

  • A. Contraindications to angiography and selective catheterization B. Known anaphylaxis to iodinated contrast C. Expected lung dose > 30Gy per a session D. Unable to avoid non-target 90Y flow into the extrahepatic organs except the lungs E. Decompensated liver cirrhosis (Child-Pugh score > 7) F. Active uncontrolled infection G. Pregnancy H. Current or history (< or = 5 years) of malignancies in the other organs I. History of liver transplantation J. Any vascular invasion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TARE
early stage hepatocellular carcinoma
Procedure: transarterial radioembolization
TARE with 90Y

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From enrollment to the end of treatment at 3 years
Overall survival
From enrollment to the end of treatment at 3 years
best target lesion response
Time Frame: "From enrollment to the end of treatment at 3 years
best target lesion response
"From enrollment to the end of treatment at 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to target lesion progression
Time Frame: From enrollment to the end of treatment at 3 years
Time to target lesion progression
From enrollment to the end of treatment at 3 years
Time to overall progression
Time Frame: From enrollment to the end of treatment at 3 years
Time to overall progression
From enrollment to the end of treatment at 3 years
Treatment-related adverse events rates
Time Frame: From enrollment to the end of treatment at 3 years
Treatment-related adverse events rates
From enrollment to the end of treatment at 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

National Cancer Center, Korea
Samsung Medical Center
Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

November 29, 2025

First Submitted That Met QC Criteria

November 29, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 29, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KURE-YTT-HCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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