Radioembolization, Hepatocellular Carcinoma (HCC), Early Stage
Conditions
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.
Interventions
PROCEDUREtransarterial radioembolization
TARE with 90Y
Sponsors
National Cancer Center, Korea
Severance Hospital
Samsung Medical Center
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From enrollment to the end of treatment at 3 years | Overall survival |
| best target lesion response | From enrollment to the end of treatment at 3 years | best target lesion response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to target lesion progression | From enrollment to the end of treatment at 3 years | Time to target lesion progression |
| Time to overall progression | From enrollment to the end of treatment at 3 years | Time to overall progression |
| Treatment-related adverse events rates | From enrollment to the end of treatment at 3 years | Treatment-related adverse events rates |
Countries
South Korea
Outcome results
None listed