Clinical Trial

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

Study acronym: STRATUM
Recruiting Phase 2
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Record status
This record was last updated October 6, 2025 (before its estimated July 25, 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-05-11; most recent amendment 2025-09-30.
Status change: Not Yet Recruiting → Recruiting 2022-09-26
Trial Details
NCT Number NCT05377034
Lead Sponsor National Cancer Centre, Singapore
Collaborators: Hoffmann-La Roche, Sirtex Medical, Singapore Clinical Research Institute
Conditions Locally Advanced Hepatocellular Carcinoma
Enrollment 100 participants
Start Date 2022-10-26
Primary Completion 2026-07-25 (estimated)
Study Completion 2028-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-06