Ablative radioembolization for liver cancer with portal vein tumor thrombosis

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

This study tests if a new treatment using tiny radioactive beads can help people with liver cancer and a specific type of blood clot in the liver feel better and stay safe.

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, Radiation
• Locations: 4 sites (Ilsan, Gyeonggi-do and 3 other locations)
• Trial ID: NCT06166576 on ClinicalTrials.gov

What this trial studies

The RESOLVE trial is an open-label, single-arm, multi-center study designed to evaluate the efficacy and safety of ablative radioembolization using TheraSphere Yttrium-90 microspheres in patients with hepatocellular carcinoma and localized portal vein tumor thrombosis. Participants will receive a targeted dose exceeding 205 Gy to the tumor and will be monitored for two years to assess treatment outcomes and safety. This trial specifically 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 unilobar hepatocellular carcinoma and localized portal vein invasion, who maintain good liver function.

Not a fit: Patients with extrahepatic metastasis or serious dysfunction of major organs may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with hepatocellular carcinoma and localized portal vein tumor thrombosis.

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

Eligibility criteria

Inclusion Criteria:

1. Adults aged 18 and over
2. Patients diagnosed with unilobar hepatocellular carcinoma, either histologically and/or radiologically (LI-RADS 4 or 5)
3. Patients with at least one measurable lesion greater than 10 mm on dynamic contrast-enhanced CT or MRI
4. Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamic contrast-enhanced CT or MRI
5. Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominal CT or MRI
6. Patients with no prior treatment for liver cancer
7. Child-Pugh class A
8. Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
9. Patients without serious dysfunction of major organs, as indicated by blood tests conducted 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 (transfusions allowed to meet this criterion)
   4. Total bilirubin ≤ 3.0 mg/dL
   5. Platelets ≥ 50,000/µL
   6. For patients not on anticoagulants, INR ≤ 2.0
   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 fully understood the clinical trial and given written consent
12. Female patients of childbearing age confirmed not to be pregnant

Exclusion Criteria:

1. Patients unsuitable for ablative radioembolization as per the pre-test with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.

   1. 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.
   2. Cases with severe hepatic artery-portal vein shunting leading to expected irradiation of the non-tumorous opposite lobe.
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 with hepatic vein or bile duct invasion as seen on dynamic contrast-enhanced CT or MRI.
4. Patients scheduled to use immunotherapy regardless of the response to radioembolization.
5. Patients who had active cancer within two years prior to joining the clinical trial.
6. Patients who have undergone surgery or procedures related to the bile duct.
7. Pregnant or breastfeeding women.

Where this trial is running

Ilsan, Gyeonggi-do and 3 other locations

• National Cancer Center — Ilsan, Gyeonggi-do, South Korea (Recruiting)
• Seoul National University Hospital — Seoul, Seoul, South Korea (Recruiting)
• Severance Hospital — Seoul, South Korea (Recruiting)
• Samsung Medical Center — Seoul, South Korea (Recruiting)

Study contacts

• Principal investigator: Jin Woo Choi, MD, PhD — Seoul National University Hospital
• Study coordinator: Jin Woo Choi, MD, PhD

Conditions Hepatocellular Carcinoma; Hepatocellular carcinoma; Radioembolization; Portal vein tumor thrombosis