Streamlining Radioembolization for Small HCC
Not yet recruiting
- Conditions
- Hepatocellular Carcinoma (HCC)
- Registration Number
- NCT06979219
- Lead Sponsor
- Seoul National University Hospital
- 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), radioembolization is performed without MAA scan with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and streamlining radioembolization is feasible and safe.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 138
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method complete response rate by mRECIST up to 1 year the proportion of CR by mRECIST at any time of the primary target tumor
- Secondary Outcome Measures
Name Time Method overall survival From date of radioembolization until the date of death from any cause, assessed up to 60 months Progression-free survival From date of radioembolization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months objective response rate up to 1 year local progression-free survival From date of radioembolization until the date of first documented progression of treated tumor or date of death from any cause, whichever came first, assessed up to 60 months
Trial Locations
- Locations (4)
National Cancer Center
🇰🇷Goyang, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance hospital
🇰🇷Seoul, Korea, Republic of