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Active, Not Recruiting

NCT Number: NCT07278102

A Prospective Observational Study on Efficacy of TARE for Early Stage HCC

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Radioembolization Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Early Stage Hepatocellular Carcinoma (HCC) Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transarterial radioembolization

Procedure

TARE with 90Y

Primary outcomes

  1. Overall survival

    Time frame: From enrollment to the end of treatment at 3 years

    Overall survival

  2. best target lesion response

    Time frame: "From enrollment to the end of treatment at 3 years

    best target lesion response

Secondary outcomes

  1. Time to target lesion progression

    Time frame: From enrollment to the end of treatment at 3 years

    Time to target lesion progression

  2. Time to overall progression

    Time frame: From enrollment to the end of treatment at 3 years

    Time to overall progression

  3. Treatment-related adverse events rates

    Time frame: From enrollment to the end of treatment at 3 years

    Treatment-related adverse events rates

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • National Cancer Center, Korea
  • Samsung Medical Center
  • Severance Hospital

Registry information

Official study title

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

Acronym: KURE-YTT-HCC

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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