Ablative radioembolization for large liver tumors

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

This study is testing a new treatment using tiny radioactive beads to see if it can safely shrink large liver tumors in people with good liver function and no previous liver cancer treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Seoul National University Hospital (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Seoul, Seoul)
• Trial ID: NCT06178198 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of ablative radioembolization using Yttrium-90 resin microspheres in patients with large hepatocellular carcinoma greater than 8 cm. The study aims to deliver an ablative dose to the tumors while preserving healthy liver tissue, potentially serving as a curative treatment or a bridge to surgery. Participants will be monitored for efficacy and safety over a two-year period. The trial focuses on patients with good liver function and no prior treatments for liver cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over with large hepatocellular carcinoma and good liver function, without prior treatments.

Not a fit: Patients with extrahepatic metastasis, vascular invasion, or those with poor liver function may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a curative option for patients with large hepatocellular carcinoma while preserving liver function.

How similar studies have performed: Other studies have shown promising results with similar radioembolization approaches, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Seoul, Seoul

• Seoul National University Hospital — Seoul, Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Jin Woo Choi, MD, PhD

Conditions Hepatocellular Carcinoma; Radioembolization