Same-day treatment for large liver tumors
Same-day Radioembolization for Large HCC (>5cm) With Y90 Resin Microspheres : Multicenter Prospective Registry Study
This study is testing if treating large liver tumors in one day with a special procedure is safe and effective for certain patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 138 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 4 sites (Goyang and 3 other locations) |
| Trial ID | NCT06944483 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with hepatocellular carcinoma larger than 5 cm, without significant vascular complications.
Not a fit: Patients with hepatic vein invasion, TIPS, or significant lung disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could streamline treatment for patients with large HCC, potentially leading to quicker interventions and improved outcomes.
How similar studies have performed: While similar approaches have been explored, this specific same-day TARE methodology is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Goyang and 3 other locations
- National Cancer Center — Goyang, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Not_yet_recruiting)
- Seoul National University Hospital — Seoul, South Korea (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.