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Hepatocellular Carcinoma (HCC)ISTAR-01NCT06944483

Same-day Radioembolization for Large HCC

An observational study of Hepatocellular Carcinoma (HCC), run by Seoul National University Hospital at 4 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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), planning angiography, MAA scan, and radioembolization are performed in a single day with SIR-Spheres. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
same-day radioembolization
Type of treatment
Surgery or procedure
How many people
138 participants
Where
4 sitesSouth Korea
Study dates
25 Apr 2025to 31 Dec 2029
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients with hepatocellular carcinoma who are scheduled for radioembolization

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hyo-Cheol Kim, MD contact

82-10-5136-5205

radioembolization@snu.ac.kr

South Korea4 sites, 4 recruiting

  • National Cancer Center

    Goyang

    In Joon Lee, 82-10-6429-2012, 2injoon@hanmail.net

    Recruiting

  • Samsung Medical Center

    Seoul

    Dong Ho Hyun, 82-10-8809-6722, mesentery@naver.com

    Not yet recruiting

  • Seoul National University Hospital

    Seoul

    Hyo-Cheol Kim, MD, 82-2-2072-0760, radioembolization@snu.ac.kr

    Recruiting

  • Severance hospital

    Seoul

    Gyoung Min Kim, 821042430703, gyoungmin@gmail.com

    Not yet recruiting

Other trials in South Korea

About this study

Official title: Same-day Radioembolization for Large HCC (>5cm) 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), planning angiography, MAA scan, and radioembolization are performed in a single day with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and same-day radioembolization is feasible and safe.

Read the detailed description

SIR-Spheres (SIRTEX): A mother vial containing ≥7 GBq is delivered to the hospital, and the treatment team divides it into daughter vials with specific radiation activities tailored to the target vessels. This allows for same-day TARE, in which lung shunt evaluation, vessel identification, dose calculation, and microsphere injection are all conducted on the same day.

This approach is referred to as same-day TARE.

To implement same-day TARE effectively, it is crucial to carefully select patients who are expected to have a low lung shunt fraction. This helps minimize the waste of pre-ordered SIR-Spheres vials that would otherwise go unused. Factors associated with a high lung shunt fraction include large tumor size, hepatic vein invasion, the presence of a transjugular intrahepatic portosystemic shunt (TIPS), and dysmorphic intratumoral vessels. In patients with tumors larger than 5 cm, the lung shunt fraction is likely to be low if there is no hepatic vein invasion, no TIPS, and no dysmorphic intratumoral vessels. Therefore, by selecting patients without dysmorphic intratumoral vessels for same-day TARE, it is possible to avoid wasting SIR-Spheres vials and perform the procedure without delays in treatment.

Furthermore, by defining safe and effective dose ranges for lung dose, tumor dose, and perfused liver dose, a standardized TARE protocol can be established. Through this study, we aim to establish appropriate patient selection criteria for same-day TARE and to standardize TARE dosimetry.

Being tested
same-day radioembolization
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • same-day radioembolizationProcedure or surgery

    On the day of the procedure, angiography is performed, followed by cone-beam CT of the hepatic artery. After injecting 99mTc-MAA into the hepatic artery, the patient is transferred to the nuclear medicine department for a lung shunt scan and lung SPECT/CT. The lung shunt fraction is determined using the planar images.

    Using diagnostic CT/MRI and 99mTc-MAA images, the treatment dose is calculated with the multi-compartment MIRD method. The acceptable range for tumor absorbed dose is ≥100 Gy, and the lung dose must be ≤15 Gy. The tumor absorbed dose must be at least 100 Gy and should ideally be within the range of 300 to 600 Gy. There is no upper limit for the tumor absorbed dose.

Study groups in NCT06944483
Study groupRoleWhat they receive
same-day groupplanning angiography, MAA scan, and radioembolization was performed in a single day
Receives: Procedure: same-day radioembolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. percentage of execution of same-day radioembolization procedure

    Execution means that planning angiography, MAA scan and radioembolization are performed in a single day. The number same-day radioembolization is divided by total enrolled patient number.

    Measured: Day 1

Secondary outcomes (4)

  1. Objective response rate

    objective response rate

    Measured: up to 1 year

  2. local progression-free survival

    Measured: 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

  3. Progression-free survival

    Measured: 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

  4. overall survival

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2025
  2. Study start25 Apr 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
138 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06944483
Sponsor's protocol ID
2503-051-1620
Acronym
ISTAR-01
Status last verified
Aug 2026
First submitted
8 Apr 2025
Last updated
18 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim HC, Suh M, Paeng JC, Choi JW. Same-Day versus Multiday Planning/Treatment Radioembolization with Yttrium-90 Resin Microspheres in Patients with Liver Cancer >/=5 cm. J Vasc Interv Radiol. 2025 Dec;36(12):2010-2020.e2. doi: 10.1016/j.jvir.2025.08.028. Epub 2025 Aug 27.

    PubMed 40882836

  • Choi TW, Joo I, Kim HC. Association of dysmorphic intratumoral vessel with high lung shunt fraction in patients with hepatocellular carcinoma. Sci Rep. 2022 Aug 21;12(1):14248. doi: 10.1038/s41598-022-18697-5.

    PubMed 35989374

  • Kim HC, Lee IJ, Hyun D, Kim GM. Same-Day Radioembolization for Large Hepatocellular Carcinoma (>/= 5 cm) Using Yttrium-90 Resin Microspheres: Protocol for a Multicenter Prospective Registry Study (ISTAR-01). Cardiovasc Intervent Radiol. 2026 Oct 7. doi: 10.1007/s00270-026-04633-x. Online ahead of print.

    PubMed 42844316

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma (HCC), run by Seoul National University Hospital at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hyo-Cheol Kim, MD (82-10-5136-5205, radioembolization@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage of execution of same-day radioembolization procedure (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06944483, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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Same-day Radioembolization for Large HCC (NCT06944483) | AzTrials