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

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.

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