NCT05377034

Multinational Phase II Trial to Compare Safety and Efficacy of SIRT (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab, vs SIRT (SIRT-Y90) Followed by Placebo in Locally Advanced HCC Patients

A Multinational, Double-blind, Placebo-Controlled, Parallel Randomized Arms, Phase II Trial to Compare Safety and Efficacy of Selective Internal Radiation Therapy (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab) Versus Selective Internal Radiation Therapy (SIRT-Y90) Followed by Placebo in Patients With Locally Advanced Hepatocellular Carcinoma (HCC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-national, phase II, parallel-arm, double-blind, placebo-controlled, two-arm study designed to assess the efficacy and safety of SIRT-Y90 followed by atezolizumab plus bevacizumab \[study arm\], versus SIRT-Y90 followed by placebo \[control arm\] in patients with locally advanced Hepatocellular Carcinoma (HCC).

Detailed description

This study will enroll 100 patients randomized in a 1:1 allocation ratio (50 in each arm) to one of the two arms. * Study arm: SIRT-Y90 + 1200mg atezolizumab + 15mg/kg bevacizumab * Control arm: SIRT-Y90 + placebos (IV) The patients will be recruited from up to 15 sites from the Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group (subjected to feasibility studies and ethics approval). Proposed sites are in Singapore, China, South Korea, and Taiwan.

Conditions

• Locally Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	SIRT-Y90 with Atezolizumab + Bevacizumab	Single or two-staged delivery of SIRT-Y90 (4 to 6 weeks), followed by 1200mg atezolizumab + 15mg/kg bevacizumab administered by IV at every 3 weeks for 18 months.
COMBINATION_PRODUCT	SIRT-Y90 with Placebo (IV)	Single or two-staged delivery of SIRT-Y90 (4 to 6 weeks), followed by placebo at every 3 weeks for 18 months.

Timeline

• Start date: 2022-10-26
• Primary completion: 2026-07-25
• Completion: 2028-01-31
• First posted: 2022-05-17
• Last updated: 2025-10-06

Locations

14 sites across 4 countries: China, Singapore, South Korea, Taiwan