Hepatocellular Carcinoma (HCC)ISTAR-02NCT06979219
Streamlining Radioembolization for Small HCC
An observational study of Hepatocellular Carcinoma (HCC), run by Seoul National University Hospital at 5 sites in South Korea.
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, tumor size < 5cm), radioembolization is performed without MAA scan 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)
- How many people
- 146 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 10 Jun 2025to 31 Dec 2029
- 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
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
National Cancer Center
Goyang
In Joon Lee, MD, 82-10-6429-2012, 2injoon@hanmail.net
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si
Kun Yung Kim, 82-31-787-2882, kky2kkw@hotmail.com
- Not yet recruiting
Samsung Medical Center
Seoul
Dong Ho Hyun, MD, 82-10-8809-6722, mesentery@naver.com
- Recruiting
Seoul National University Hospital
Seoul
Hyo-Cheol Kim, MD, 82-10-5136-5205, radioembolization@snu.ac.kr
- Not yet recruiting
Severance hospital
Seoul
Gyoung Min Kim, 821042430703, gyoungmin@gmail.com
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Streamlining group | radioembolization is performed without MAA scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate by mRECIST
the proportion of CR by mRECIST at any time of the primary target tumor
Measured: up to 1 year
Secondary outcomes (4)
objective response rate
Measured: up to 1 year
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
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
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.
- First posted18 May 2025
- Study start10 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Cheol Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979219
- Sponsor's protocol ID
- 2503-052-1620
- Acronym
- ISTAR-02
- Status last verified
- Aug 2026
- First submitted
- 11 May 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32145255Kim 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.
PubMed 39401745
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Streamlining Radioembolization for HCC ≤ 5 cm With Y90 Resin Microspheres : Multicenter Prospective Registry Study
- ClinicalTrials.gov ID
- NCT06979219
- Acronym / sponsor ID
- ISTAR-02 / 2503-052-1620
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Streamlining group | – | –radioembolization is performed without MAA scan |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with hepatocellular carcinoma who are scheduled for radioembolization
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 32145255Gabr 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.
- Background: PubMed 39401745Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by Seoul National University Hospital at 5 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 11 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 5 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?
complete response rate by mRECIST (time frame: up to 1 year). 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 NCT06979219, which also lists 2 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.