Streamlining Radioembolization for Small HCC

Official title

Streamlining Radioembolization for HCC ≤ 5 cm With Y90 Resin Microspheres : Multicenter Prospective Registry Study

Overview

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.

Primary outcome measures

• complete response rate by mRECIST [Time frame: up to 1 year]

Secondary outcome measures (4)

• objective response rate [Time frame: up to 1 year]
• local progression-free survival [Time frame: 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]
• Progression-free survival [Time frame: 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]
• overall survival [Time frame: From date of radioembolization until the date of death from any cause, assessed up to 60 months]

Eligibility criteria

Inclusion criteria

• adults aged >18 years
• Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5)
• hepatocellular carcinoma 5cm or smaller
• Tumor number is 3 or smaller
• Dysmorphic intratumoral vessel is absent or smaller than 3 mm
• 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/MRI
• Dysmorphic intratumoral vessel ≥3mm
• Patient with transjugular intrahepatic portosystemic shunt
• Patient with bilioenteric anastomosis or biliary stent
• Patient with centrilobular emphysema or interstitial lung disease
• main portal vein invasion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

South Korea · 4 centers

• National Cancer Center — Goyang
• Samsung Medical Center — Seoul
• Seoul National University Hospital — Seoul
• Severance hospital — Seoul

Publications

• Gabr A, Ranganathan S, Mouli SK, Riaz A, Gates VL, Kulik L, Ganger D, Maddur H, Moore C, Hohlastos E, Katariya N, Caicedo JC, Kalyan A, Lewandowski RJ, Salem R. Streamlining radioembolization in UNOS T1/T2 hepatocellular carcinoma by eliminating lung shunt estimation. J Hepatol. 2020 Jun;72(6):1151-1158. doi: 10.1016/j.jhep.2020.02.024. Epub 2020 Mar 5. PMID 32145255
• Kim HC, Suh M, Paeng JC, Lee JH, Lee M, Chung JW, Choi JW. Streamlining Radioembolization without Lung Shunt Estimation versus Regular Radioembolization in Patients with Hepatocellular Carcinoma within the Milan Criteria. J Vasc Interv Radiol. 2025 Jan;36(1):78-87.e1. doi: 10.1016/j.jvir.2024.10.007. Epub 2024 Oct 12. PMID 39401745

Identifiers

NCT: NCT06979219 · 2503-052-1620

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗