Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma

An Open-label, Single-arm, Single-center Clinical Trial to Evaluate the Efficacy and Safety of Yttrium-90 Ablative Radioembolization (Radiation Major Hepatectomy) for Unifocal Large Hepatocellular Carcinoma

Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma (NCT06178198) is a Phase 2 interventional studying Hepatocellular Carcinoma, 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

The RESCUE trial is a prospective, single-arm clinical study to evaluate the efficacy and safety of ablative radioembolization using Yttrium-90. This treatment is being investigated as a potential curative approach, as well as a bridging or downstaging strategy for surgery, in patients with large hepatocellular carcinoma (greater than 8 cm) who maintain good liver function.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hepatocellular Carcinoma 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.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adults aged 18 and over. 2. Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5). 3. Patients with no more than five lesions in dynamic contrast-enhanced CT or MRI, and the largest tumor diameter exceeding 8 cm. 4. Patients without vascular invasion and bile duct invasion in dynamic contrast-enhanced CT or MRI. 5. Patients with no extrahepatic metastasis in lung CT and contrast-enhanced abdominal CT or MRI. 6. Patients with no prior treatment for liver cancer. 7. Child-Pugh class A. 8. You should be able to carry out daily activities with 1 level of ability (ECOG 1) or less. 9. Patients with no major organ dysfunction according to blood tests performed within one month of study enrollment. 1. Leukocytes ≥ 2,500/µL and ≤ 12,000/µL 2. Absolute neutrophil count ≥ 1,500 /mm\^3 3. blood count (hemoglobin) at least 8.0 g/dL (transfusion allowed to meet this criterion) 4. Total bilirubin ≤ 3.0 mg/dL 5. platelet count at least 50,000/µL 6. INR ≤ 2.0 for patients not taking anticoagulants 7. AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) 8. ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) 9. ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit) 10. Creatinine ≤ 2.0 mg/dL 10. Patients with a life expectancy of more than 3 months. 11. Patients who have adequately understood the clinical trial and consented in writing. 12. Non-pregnant women of childbearing potential. Who Should NOT Join This Trial: 1. Patients who are not suitable for ablative radioembolization as indicated by pre-treatment testing with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization. 1. Cases where the estimated lung dose exceeds 15 Gy when 150 Gy of absorbed dose is administered to the tumor based on the partition method. 2. Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments. ...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: 1. Adults aged 18 and over. 2. Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5). 3. Patients with no more than five lesions in dynamic contrast-enhanced CT or MRI, and the largest tumor diameter exceeding 8 cm. 4. Patients without vascular invasion and bile duct invasion in dynamic contrast-enhanced CT or MRI. 5. Patients with no extrahepatic metastasis in lung CT and contrast-enhanced abdominal CT or MRI. 6. Patients with no prior treatment for liver cancer. 7. Child-Pugh class A. 8. ECOG performance status of 1 or less. 9. Patients with no major organ dysfunction according to blood tests performed within one month of study enrollment. 1. Leukocytes ≥ 2,500/µL and ≤ 12,000/µL 2. Absolute neutrophil count ≥ 1,500 /mm\^3 3. Hemoglobin ≥ 8.0 g/dL (transfusion allowed to meet this criterion) 4. Total bilirubin ≤ 3.0 mg/dL 5. Platelet ≥ 50,000/µL 6. INR ≤ 2.0 for patients not taking anticoagulants 7. AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) 8. ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit) 9. ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit) 10. Creatinine ≤ 2.0 mg/dL 10. Patients with a life expectancy of more than 3 months. 11. Patients who have adequately understood the clinical trial and consented in writing. 12. Non-pregnant women of childbearing potential. Exclusion Criteria: 1. Patients who are not suitable for ablative radioembolization as indicated by pre-treatment testing with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization. 1. Cases where the estimated lung dose exceeds 15 Gy when 150 Gy of absorbed dose is administered to the tumor based on the partition method. 2. Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments. 2. Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume. 3. Patients scheduled to use immunotherapy irrespective of the response to radioembolization. 4. Patients who have had active cancer within the last two years prior to the clinical trial participation. 5. Patients who have undergone surgery or procedures related to the bile duct. 6. Women who are pregnant or breastfeeding.

Treatments Being Tested

PROCEDURE

Ablative radioembolization using Yttrium-90 resin microspheres

Based on 99mTc-MAA mapping, a partition model (multi-compartment MIRD) is employed to plan for a radiation dose of 400 (± 30%) to the tumor. If delivering this dose to the tumor is challenging due to lung dose limitations, the maximum feasible dose is administered to the tumor while maintaining the estimated lung dose below 15 Gy. While treating the entire tumor with a single high-dose radioembolization session is preferred, if necessary due to considerations like estimated lung dose, the treatment can be divided into two sessions, keeping the cumulative lung dose below 25 Gy. For any methods not covered in this discussion, refer to the SIR-Sphere user manual by Sirtex.

Locations (1)

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.

Seoul National University Hospital

Seoul, Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06178198), 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 NCT06178198 clinical trial studying?

Who can participate in NCT06178198?

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 NCT06178198?

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 NCT06178198. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06178198. 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 2026-05-08 · Data from ClinicalTrials.gov.