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Recruiting
NCT06944483
Same-day Radioembolization for Large HCC
Conditions: Hepatocellular Carcinoma (HCC)
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Enrollment: 138
Sponsor: Seoul National University Hospital
Location: National Cancer Center Goyang
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 scan, and radioembolization are performed in a single day with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and same-day radioembolization is feasible and safe.
Eligibility Criteria
Inclusion Criteria:
* Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5)
* 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)
* Patients with a life expectancy of \>3 mo
* Patients who have adequately understood the clinical trial and consented in writing
* Nonpregnant women of childbearing potential
Exclusion Criteria:
* hepatic vein invasion on CT/MRI
* Marked enhancement of portal vein or hepatic vein on arterial phase of CT/MRII
* TIPS
* dysmorphic intratumoral vessels \> 3mm
* main portal vein invasion
* significant COPD or interstitial lung disease
* biliary stent or enterobiliary anastomosis
Source: ClinicalTrials.gov (NCT06944483). StuddyBuddy aggregates publicly available trial information.