drugset / Trial / 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
Phase 2
Recruiting
100 enrolled
National Cancer Centre, Singapore
Hoffmann-La Roche · collabSingapore Clinical Research Institute · collabSirtex Medical · collab
RandomizedParallel-groupQuadruple-blindTreatment
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).
Timeline
- Start
- 2022-10-26
- Primary completion
- 2026-07-25
- Completion
- 2028-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Background | Y-90 Resin Microspheres | Unknown | — | — |