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

NCT07278102 | Active Not Recruiting DMC

• 1 other identifier: KURE-YTT-HCC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Stage; Radioembolization; Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Overall survival

  From enrollment to the end of treatment at 3 years

• best target lesion response

  best target lesion response

  "From enrollment to the end of treatment at 3 years

Secondary Outcomes (3)

• Time to target lesion progression

  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

  From enrollment to the end of treatment at 3 years

Study Arms (1)

TARE

early stage hepatocellular carcinoma

Procedure: transarterial radioembolization

Interventions

transarterial radioembolization PROCEDURE

TARE with 90Y

TARE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: collaborator
• Severance Hospital: collaborator
• Samsung Medical Center: collaborator
• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2025
• First Posted: December 11, 2025
• Study Start: March 28, 2022
• Primary Completion: January 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)