Status:
RECRUITING
Streamlining Radioembolization for Small HCC
Lead Sponsor:
Seoul National University Hospital
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
19+ years
Brief Summary
In patients who has no sign suggesting high lung shunt fraction (TIPS, hepatic vein invasion, hepatic vein enhancement on arterial phase, dysmorphic intratumoral vessel, tumor size \< 5cm), radioembol...
Eligibility Criteria
Inclusion
- HCC can be diagnosed by AASLD guideline
- hepatocellular carcinoma 5cm or smaller
- dysmorphic intratumoral vessels 3mm or smaller
- Child-Pugh class A
- ECOG 0 or 1
- the following lab should be met. A. Leukocytes ≥ 1,000/µL and ≤ 20,000/µL B. Hemoglobin ≥ 6.0 g/dL (transfusion allowed to meet this criterion) C. Total bilirubin ≤ 2.0 mg/dL D. Platelet ≥ 40,000/µL E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants F. Aspartate transaminase (AST) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) G. Alanine transaminase (ALT) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) H. Creatinine ≤ 2.5 mg/dL (if patient is receiving hemodialysis, no upper limit of creatinine)
Exclusion
- hepatic vein invasion on CT/MRI
- hepatic vein enhancement on arterial phase of CT/MRI
- TIPS
- dysmorphic intratumoral vessels \> 3mm
- main portal vein invasion
- significant COPD or interstitial lung disease
- biliary stent or bilioenteric anastomosis
Key Trial Info
Start Date :
June 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT06979219
Start Date
June 10 2025
End Date
December 31 2029
Last Update
July 28 2025
Active Locations (4)
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1
National Cancer Center
Goyang, South Korea
2
Samsung Medical Center
Seoul, South Korea
3
Seoul National University Hospital
Seoul, South Korea
4
Severance hospital
Seoul, South Korea