Streamlining Radioembolization for Small HCC

NCT06979219 | Recruiting

• 1 other identifier: 2503-052-1620
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 4

Brief 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, 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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• complete response rate by mRECIST

  the proportion of CR by mRECIST at any time of the primary target tumor

  up to 1 year

Secondary Outcomes (4)

• objective response rate

  up to 1 year

• local progression-free survival

  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

  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

  From date of radioembolization until the date of death from any cause, assessed up to 60 months

Study Arms (1)

Streamlining group

radioembolization is performed without MAA scan

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with hepatocellular carcinoma who are scheduled for radioembolization

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (4)

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

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Hyo-Cheol Kim, MD

CONTACT

82-10-5136-5205; radioembolization@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 9, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)