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Hepatocellular CarcinomaPhase 2RESOLVENCT06166576

Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis

A Phase 2 study testing Ablative radioembolization in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 5 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

The RESOLVE trial, an open-label, single-arm, multi-center study, aims to assess the efficacy and safety of ablative radioembolization using TheraSphere Yttrium-90 microspheres. This trial specifically targets patients diagnosed with hepatocellular carcinoma accompanied by localized portal vein tumor thrombosis… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Ablative radioembolization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesSouth Korea
Study dates
20 Nov 2023to 30 Nov 2027
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 and over
  • Patients diagnosed with unilobar hepatocellular carcinoma, either histologically and/or radiologically (LI-RADS 4 or 5)
  • Patients with at least one measurable lesion greater than 10 mm on dynamic contrast-enhanced CT or MRI
  • Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamic contrast-enhanced CT or MRI
  • Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominal CT or MRI
  • Patients with no prior treatment for liver cancer
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  • Child-Pugh class A
  • Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
  • Patients without serious dysfunction of major organs, as indicated by blood tests conducted within one month of study enrollment
  • Leukocytes ≥ 2,500/µL and ≤ 12,000/µL
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Hemoglobin ≥ 8.0 g/dL (transfusions allowed to meet this criterion)
  • Total bilirubin ≤ 3.0 mg/dL
  • Platelets ≥ 50,000/µL
  • For patients not on anticoagulants, INR ≤ 2.0
  • AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
  • ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
  • ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit)
  • Creatinine ≤ 2.0 mg/dL
  • Patients with a life expectancy of more than 3 months
  • Patients who have fully understood the clinical trial and given written consent
  • Female patients of childbearing age confirmed not to be pregnant

Who cannot join

  • Patients unsuitable for ablative radioembolization as per the pre-test with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.
  • Cases where, according to multi-compartment Medical Internal Radiation Dose method, delivering 205 Gy of radiation to the tumor exceeds an estimated lung dose of 25 Gy.
  • Cases with severe hepatic artery-portal vein shunting leading to expected irradiation of the non-tumorous opposite lobe.
  • Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume.
  • Patients with hepatic vein or bile duct invasion as seen on dynamic contrast-enhanced CT or MRI.
  • Patients scheduled to use immunotherapy regardless of the response to radioembolization.
Show all 9Show fewer
  • Patients who had active cancer within two years prior to joining the clinical trial.
  • Patients who have undergone surgery or procedures related to the bile duct.
  • Pregnant or breastfeeding women.

Trial locations and contacts

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

Jin Woo Choi, MD, PhD contact

+82-220722584

jwchoi.med@snu.ac.kr

5 sites in 1 country

South Korea5 sites, 5 recruiting
  • National Cancer Center

    Ilsan, Gyeonggi-do, 10408

    In Joon Lee, MD, PhD, +82 319200114, 2injoon@hanmail.net

    In Joon Lee, MD, PhD

    Recruiting
  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Gun Young Kim, +82 317877619, kky2kkw@gmail.com

    Gun Young Kim, MD, PhD

    Recruiting
  • Seoul National University Hospital

    Seoul, Seoul, 03080

    Jin Woo Choi, MD, PhD, +82-220722584, jwchoi.med@snu.ac.kr

    Jin Woo Choi, MD, PhD

    Recruiting
  • Severance Hospital

    Seoul, 03722

    Gyoung Min Kim, kimgm@yonsei.ac.kr

    Gyoung Min Kim, MD, PhD

    Recruiting
  • Samsung Medical Center

    Seoul, 06351

    Dong-Ho Hyun, MD, PhD, mesentery@naver.com

    Dong-Ho Hyun, MD, PhD

    Recruiting

Other trials in South Korea

About this study

Official title: An Open-label, Prospective, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Ablative Radioembolization Using Yttrium-90 Glass Microspheres in Patients With Locally-advanced Hepatocellular Carcinoma

The RESOLVE trial, an open-label, single-arm, multi-center study, aims to assess the efficacy and safety of ablative radioembolization using TheraSphere Yttrium-90 microspheres. This trial specifically targets patients diagnosed with hepatocellular carcinoma accompanied by localized portal vein tumor thrombosis (Vp1-Vp3) and who maintain good liver function.

Read the detailed description

Patients diagnosed with unilobar hepatocellular carcinoma and localized portal vein tumor thrombosis (Vp1-Vp3), who also exhibit good liver function, will undergo ablative radioembolization with a dose exceeding 205 Gy to the tumor using TheraSphere glass microspheres. These patients will be monitored over a two-year period to evaluate their clinical course, treatment outcomes, and safety.

Being tested
Ablative radioembolization
Keywords
Hepatocellular carcinoma, Radioembolization, Portal vein tumor thrombosis
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Ablative radioembolizationProcedure or surgery

    The interventional radiologist utilizes a pre-test with 99mTc-MAA SPECT-CT and cone-beam CT for procedural planning. For tumors confined to a single segment, the treatment area is planned to receive a radiation dose of over 400 Gy using the single-compartment MIRD technique. For tumors extending beyond a single segment, the multi-compartment MIRD technique is used to plan a radiation dose of 700 Gy (± 20%) to the tumor. The upper limit for the estimated lung dose is set at 25 Gy, and the upper limit for the perfused non-tumoral liver dose is 250 Gy. In cases where tumors extending beyond a single segment cannot receive the planned dose of 700 Gy (± 20%) due to limits on lung or normal liver dose, the plan is adjusted to deliver the maximum dose to the tumor within the permissible range for lung and normal liver doses. Radioembolization is typically performed in a single session, and any methods not mentioned here should follow the instructions for use of TheraSphere.

Study groups in NCT06166576
Study groupRoleWhat they receive
RadioembolizationExperimentalHepatocellular carcinoma with localized portal vein tumor thrombosis (Vp1-Vp3) will be treated by ablative radioembolization using TheraSphere (Boston Scientific) glass microspheres
Receives: Procedure: Ablative radioembolization

What is being measured

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

  1. Overall survival

    Measured: Time of treatment up to participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

Secondary outcomes (23)
  1. Objective response rate according to mRECIST

    Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  2. Duration of response according to mRECIST

    Measured: Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  3. 2-year restricted mean duration of response according to localized mRECIST and mRECIST

    Measured: Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or 24 months after the initial treatment

  4. Complete response rate according to localized mRECIST and mRECIST

    Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  5. Duration of complete response according to localized mRECIST and mRECIST

    Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  6. 2-year restricted mean DoCR (RMDoCR) according to localized mRECIST and mRECIST

    Measured: Time of complete response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or 24 months after the initial treatment

  7. Best response within 2-years according to localized mRECIST and mRECIST

    Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  8. Time to best response according to localized mRECIST and mRECIST

    Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  9. Time to progression according to localized mRECIST and mRECIST

    Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  10. 2-year restricted mean survival time of overall survival

    Measured: Time of treatment up to participant's death, opposition to data collection, lost to follow-up, or 24 months the initial treatment

  11. Progression-free survival

    Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  12. Hepatic progression-free survival

    Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  13. Pathological necrosis rate (%) after curative resection or liver transplantation

    Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  14. Time to subsequent HCC treatment

    Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  15. Reason for subsequent HCC treatment

    Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  16. Rate for conversion to curative resection and liver transplantation

    Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  17. Adverse event and serious adverse event

    Common Terminology Criteria for Adverse Events v5.0

    Measured: Time of treatment up to 90 days after the initial treatment or subsequent anticancer treatment, whichever comes first

  18. Changes in Child-Pugh class

    Measured: Baseline up to 90 days after the initial treatment or subsequent anticancer treatment, whichever comes first

  19. Changes in ALBI (albumin-bilirubin) grade

    Measured: Baseline up to 90 days after the initial treatment or subsequent anticancer treatment, whichever comes first

  20. Changes in MELD (Model for end-stage liver disease) score

    Measured: Baseline up to 90 days after the initial treatment or subsequent anticancer treatment, whichever comes first

  21. Changes in ECOG (Eastern Cooperative Oncology Group) performance status scale

    0 (fully active) to 5 (dead)

    Measured: Baseline up to 90 days after the initial treatment or subsequent anticancer treatment, whichever comes first

  22. Objective response rate according to localized mRECIST

    The number of patients with partial or complete response as the best local response divided by the total number of participants

    Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

  23. Duration of response according to localized mRECIST

    The time from first documentation of partial or complete response to the first documentation of progressive disease, death due to any cause, or receipt of subsequent anticancer treatment, whichever comes first

    Measured: Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)

Timeline

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

  1. First posted12 Dec 2023
  2. Study start20 Nov 2023
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06166576
Sponsor's protocol ID
D-2306-207-1446
Acronym
RESOLVE
Status last verified
Aug 2026
First submitted
30 Nov 2023
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Choi JW, Kim GM, Hyun D, Jang MJ, Kim HC. Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma with Localized Portal Vein Tumor Thrombosis (RESOLVE): Protocol for an Open-label, Multi-center, Single-arm Trial. Cardiovasc Intervent Radiol. 2025 Mar;48(3):398-404. doi: 10.1007/s00270-024-03935-2. Epub 2025 Feb 13.

    PubMed 39948248

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ablative radioembolization in people with Hepatocellular Carcinoma, 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 22 inclusion and 9 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 20 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Jin Woo Choi, MD, PhD (+82-220722584, jwchoi.med@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Time of treatment up to participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)). 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 NCT06166576, which also lists 1 linked publication.

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 20 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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