Streamlining Radioembolization for Small HCC (ISTAR-02)

April 5, 2026 updated by: Hyo-Cheol Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with hepatocellular carcinoma who are scheduled for radioembolization

Description

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:

  1. Hepatic vein invasion on CT/MRI
  2. Marked enhancement of portal vein or hepatic vein on arterial phase of CT/MRI
  3. Dysmorphic intratumoral vessel ≥3mm
  4. Patient with transjugular intrahepatic portosystemic shunt
  5. Patient with bilioenteric anastomosis or biliary stent
  6. Patient with centrilobular emphysema or interstitial lung disease
  7. main portal vein invasion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Streamlining group
radioembolization is performed without MAA scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete response rate by mRECIST
Time Frame: up to 1 year
the proportion of CR by mRECIST at any time of the primary target tumor
up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
From date of radioembolization until the date of death from any cause, assessed up to 60 months
objective response rate
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

May 11, 2025

First Submitted That Met QC Criteria

May 11, 2025

First Posted (Actual)

May 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 5, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2503-052-1620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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