NCT06707233

Y-90 SIRT for Unresectable HCC Larger Than 7cm

Y-90 Selective Internal Radiation Therapy for Unresectable Hepatocellular Carcinoma Larger Than 7cm: a Prospective, Single Arm Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).

Conditions

• Hepatocellular Carcinoma Non-Resectable

Interventions

Type	Name	Description
PROCEDURE	SIRT	The patients will receive 1-2 sessions of SIRT.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-11-30
• Completion: 2027-11-30
• First posted: 2024-11-27
• Last updated: 2025-01-28

Locations

2 sites across 1 country: China