Same-day Radioembolization for Large HCC

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called same-day radioembolization for patients with a type of liver cancer known as hepatocellular carcinoma (HCC). The trial aims to see if this treatment, which involves using special beads to deliver radiation directly to the tumor, can be safely and effectively done in a single day. To be eligible, patients must be diagnosed with HCC that is at least 5 centimeters in size, have certain health criteria met, and have specific types of blood tests within normal ranges.

Participants in the trial can expect to undergo a series of tests and procedures on the same day, including a planning angiography (a type of imaging to look at blood vessels) and the radioembolization itself. It's important to note that certain conditions, like having major blood vessel involvement or serious lung diseases, would exclude someone from participating in this study. The goal is to demonstrate that this approach is both feasible and safe for suitable patients with large liver tumors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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
• • biliary stent or enterobiliary anastomosis