NCT05705791

Clinical Investigation Evaluating Safety and Efficacy of Selective Intra-arterial 166Holmium Radiation Therapy in Combination With Atezolizumab and Bevacizumab for Non Resectable Hepatocellular Carcinoma

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the added value of 166Holmium SIRT to Atezolizumab-Bevacizumab in patients with non resectable HCC. The primary endpoint is the Best Objective Response Rate at 6 months after 166Holmium SIRT according to mRECIST. Participants will be treated by : * Approved first line systemic therapy: Atezolizumab (1200mg Q3W, IV) with Bevacizumab (15mg/kg Q3W, IV) * In combination with 166Holmium selective internal intra-arterial radiation therapy (Quirem Spheres®, the investigational medical device) after a work-up phase considered as "favorable". Participants will be followed up to 12 months after the first cycle of Atezolizumab and Bevacizumab therapy.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DEVICE	QuiremSpheres	166Holmium selective internal intra-arterial radiation therapy at C1D15 of the Atezolizumab and Bevacizumab therapy

Timeline

• Start date: 2023-02-07
• Primary completion: 2026-02-01
• Completion: 2026-08-01
• First posted: 2023-01-31
• Last updated: 2024-07-05

Locations

6 sites across 1 country: France