Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized 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
Seoul National University Hospital
30 participants
Nov 20, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria22
- 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
Exclusion Criteria9
- 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.
Interventions
The interventional radiologist utilizes a pre-test with 99mTc-MAA SPECT-CT and cone-beam CT for procedural planning. For tumors confined to a single segment, the treatment area is planned to receive a radiation dose of over 400 Gy using the single-compartment MIRD technique. For tumors extending beyond a single segment, the multi-compartment MIRD technique is used to plan a radiation dose of 700 Gy (± 20%) to the tumor. The upper limit for the estimated lung dose is set at 25 Gy, and the upper limit for the perfused non-tumoral liver dose is 250 Gy. In cases where tumors extending beyond a single segment cannot receive the planned dose of 700 Gy (± 20%) due to limits on lung or normal liver dose, the plan is adjusted to deliver the maximum dose to the tumor within the permissible range for lung and normal liver doses. Radioembolization is typically performed in a single session, and any methods not mentioned here should follow the instructions for use of TheraSphere.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06166576