NCT06166576

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients diagnosed with unilobar hepatocellular carcinoma and localized portal vein tumor thrombosis (Vp1-Vp3), who also exhibit good liver function, will undergo ablative radioembolization with a dose exceeding 205 Gy to the tumor using TheraSphere glass microspheres. These patients will be monitored over a two-year period to evaluate their clinical course, treatment outcomes, and safety.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Ablative 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.

Timeline

• Start date: 2023-11-20
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2023-12-12
• Last updated: 2025-04-23

Locations

4 sites across 1 country: South Korea