Same-day treatment for large liver tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the feasibility and safety of performing same-day radioembolization for patients with large hepatocellular carcinoma (HCC) who meet specific selection criteria. The approach involves conducting planning angiography, MAA scans, and radioembolization in a single day using SIR-Spheres. By carefully selecting patients with low lung shunt fractions, the study aims to minimize waste of treatment resources and establish standardized protocols for the procedure. The goal is to demonstrate that same-day TARE is both effective and safe for eligible patients.

Why it matters

Who can join: the full rules

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

Where it's running

• National Cancer Center
  Goyang, South Korea Recruiting
• Seoul National University Hospital
  Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, South Korea Not yet recruiting
• Severance hospital
  Seoul, South Korea Not yet recruiting

Study contacts

• Study coordinator: Hyo-Cheol Kim, MD
• Email: radioembolization@snu.ac.kr
• Phone: 82-10-5136-5205

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.