RecruitingPhase 2NCT06166576

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

Sponsor

Seoul National University Hospital

Enrollment

30 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests radioembolization — a procedure where tiny radioactive beads are injected into the blood vessels feeding the liver tumor — as an early treatment for hepatocellular carcinoma (primary liver cancer). The study evaluates whether giving this treatment early, combined with or before other therapies, improves outcomes. **You may be eligible if...** - You are 18 or older with hepatocellular carcinoma (liver cancer) - Your liver function is adequate (Child-Pugh score A or B) - Your cancer is confined to the liver or has limited spread - You have not had prior treatment or this is being used as a next step **You may NOT be eligible if...** - You have severe liver failure or major complications from portal hypertension - Your cancer has spread extensively outside the liver - Blood flow testing shows the beads would travel to unsafe areas (like the lungs) - You have a serious condition that prevents the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREAblative radioembolization

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.