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

Recruiting now · Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT06166576

Run by

Seoul National University Hospital

People needed

30

Starts

2023-11-20

Expected to finish

2027-11-30

Last updated by the study team

2025-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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