Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria

Building Evidence for Ablative Internal Radiation Therapy Using Yttrium-90 Glass Microspheres in Localized Hepatocellular Carcinoma Beyond the Up-To-7 Criteria

Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria (NCT06773845) is a Phase 2 interventional studying Hepatocellular Carcinoma (HCC) and Radioembolization, sponsored by Seoul National University Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

At four major centers in Korea, patients with hepatocellular carcinoma (HCC) that exceed the up-to-7 criteria yet remain locally confined will undergo ablative radioembolization using Yttrium-90 glass microspheres, guided by a standardized dosimetry method. Their treatment response, survival outcomes, and adverse events will be monitored for two years following the procedure.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hepatocellular Carcinoma (HCC) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Hepatocellular Carcinoma (HCC) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion criteria - Adult aged 19 and over - HCC diagnosed by histology or non-invasive criteria of the American Association for the Study of Liver Disease - Unresectable HCC beyond the UT7 criteria: the sum of the diameter of the largest tumor (cm) and the number of tumors \> 7 - Localized HCC: all tumors are in the one to five geographically adjacent Couinaud segments - No current or previous HCC in the untreated liver (i.e., future liver remnant \[FLR\]) - FLR volume \> 30% of total non-tumorous liver volume - Child-Pugh class A - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 - No major organ dysfunction according to blood test performed within two months of study enrollment: - Leukocytes ≥ 2,000/µL and ≤ 15,000/µL - blood count (hemoglobin) at least 8.0 g/dL (transfusion allowed to meet this criterion) - Total bilirubin ≤ 2.0 mg/dL - platelet count at least 40,000/µL - International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants - Aspartate transaminase (AST) ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) - Alanine transaminase (ALT) ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) - Creatinine ≤ 2.5 mg/dL - Patients with a life expectancy of more than 3 months - For women of childbearing age, a negative serum pregnancy test - Patients who have adequately understood the clinical trial and consented in writing Who Should NOT Join This Trial: - HCC with vascular invasion and/or bile duct invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI) - HCC with extrahepatic spread on chest CT and abdominal CT or MRI - Multinodular disseminated HCC: largest tumor size \< 6 cm, or number of tumors \> 10 - Patients who are not suitable for ablative radioembolization as indicated by pre-treatment mapping with 99mTc-macroaggregated albumin (MAA): ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion criteria * Adult aged 19 and over * HCC diagnosed by histology or non-invasive criteria of the American Association for the Study of Liver Disease * Unresectable HCC beyond the UT7 criteria: the sum of the diameter of the largest tumor (cm) and the number of tumors \> 7 * Localized HCC: all tumors are in the one to five geographically adjacent Couinaud segments * No current or previous HCC in the untreated liver (i.e., future liver remnant \[FLR\]) * FLR volume \> 30% of total non-tumorous liver volume * Child-Pugh class A * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * No major organ dysfunction according to blood test performed within two months of study enrollment: * Leukocytes ≥ 2,000/µL and ≤ 15,000/µL * Hemoglobin ≥ 8.0 g/dL (transfusion allowed to meet this criterion) * Total bilirubin ≤ 2.0 mg/dL * Platelet ≥ 40,000/µL * International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants * Aspartate transaminase (AST) ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) * Alanine transaminase (ALT) ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) * Creatinine ≤ 2.5 mg/dL * Patients with a life expectancy of more than 3 months * For women of childbearing age, a negative serum pregnancy test * Patients who have adequately understood the clinical trial and consented in writing Exclusion Criteria: * HCC with vascular invasion and/or bile duct invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI) * HCC with extrahepatic spread on chest CT and abdominal CT or MRI * Multinodular disseminated HCC: largest tumor size \< 6 cm, or number of tumors \> 10 * Patients who are not suitable for ablative radioembolization as indicated by pre-treatment mapping with 99mTc-macroaggregated albumin (MAA): * Cases where the estimated lung dose exceeds 30 Gy when 350 Gy of tumor absorbed dose is administered to the tumor based on the multicompartment Medical Internal Radiation Dose (MIRD) model * Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments * Cases where the operator determines that there is substantial adhesion with the surrounding organs such as the bowel, making ablative radioembolization infeasible * Cases where the operator judges that the occurrence of even mild radiation pneumonitis could be fatal, based on marked emphysema or interstitial lung disease findings on chest CT * Patients who have had active cancer within the last two years prior to the study enrollment * History of severe allergy of intolerance to contrast agents * Contraindication to angiography or selective visceral catheterization

Treatments Being Tested

DEVICE

TheraSphere

The multicompartment MIRD model (a.k.a. partition model) based on diagnostic CT/MRI and 99mTc-MAA SPECT-CT will be used to plan a targeted dose of 700 Gy (± 50%) to the tumor. Given the high tumor burden, a scheduled second radioembolization within 120 days from the initial treatment will be permitted at the discretion of the operators provided the cumulative lung dose remains below 50 Gy. A scheduled second radioembolization may be considered when the largest tumor diameter exceeds 8 cm, or the estimated lung dose reaches 30 Gy while the tumor absorbed dose remains below the target dose of 700 Gy. The radioactive microsphere delivery device used will be glass-based (TheraSphere; Boston Scientific, MA, USA), in which Y90 is an integral constituent of the biocompatible glass matrix. Dosimetry planning will be made by personalized dosimetry software (Simplicit90y; Boston Scientific).

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Cancer Center

Ilsan, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06773845), the sponsor (Seoul National University Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06773845 clinical trial studying?

Who can participate in NCT06773845?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06773845?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06773845. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06773845. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.