Status:
RECRUITING
Same-day Radioembolization for Large 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), planning angiography, MAA sca...
Detailed Description
SIR-Spheres (SIRTEX): A mother vial containing ≥7 GBq is delivered to the hospital, and the treatment team divides it into daughter vials with specific radiation activities tailored to the target vess...
Eligibility Criteria
Inclusion
- HCC can be diagnosed by AASLD guideline
- hepatocellular carcinoma 5cm or larger
- 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 enterobiliary anastomosis
Key Trial Info
Start Date :
April 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06944483
Start Date
April 25 2025
End Date
December 31 2029
Last Update
July 16 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