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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-28

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Radioembolization Hepatocellular Carcinoma (HCC) Early Stage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TARE

early stage hepatocellular carcinoma

transarterial radioembolization

Intervention Type PROCEDURE

TARE with 90Y

Interventions

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transarterial radioembolization

TARE with 90Y

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No