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SIRT-Y90 with Atezolizumab+ Bevacizumab

Phase 2

Locally Advanced Hepatocellular Carcinoma | Monoclonal antibody | Oncology |Roche Holding AG|Trials Updated: Oct 20, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment119

FDA Designations

No designations recorded

SIRT-Y90 with Atezolizumab+ Bevacizumab clinical trials

SIRT-Y90 with Atezolizumab+ Bevacizumab · 1 trial · 1 indication

Phase 2 1
NCT05377034Multinational 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 PatientsLocally Advanced Hepatocellular Carcinoma
ACTIVE NOT_RECRUITING119 Analytics
PHASE2ACTIVE NOT_RECRUITING
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
Locally Advanced Hepatocellular Carcinoma
NCT05377034119
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Study Endpoints

Primary Endpoints

Best Overall Response Rate (BORR) at 9 months post-randomization.
9 months post-randomization.

The number of patients whose Best Overall Response (BOR) at 9 months post-randomization is a partial response or complete response per RECIST v1.1 and mRECIST, divided by the total number of patients in the analysis population.

Secondary Endpoints

Best Overall Response Rate (BORR) at 12-months and 18-months post-randomization.
12 months and 18 months post-randomization.
Sustained response rates at 9, 12 and 18 months.
9,12 and 18 months post-randomization.
Disease control rates at 9, 12 and 18 months.
9,12 and 18 months post-randomization.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Study ArmEXPERIMENTALSIRT-Y90 + 1200mg atezolizumab + 15mg/kg bevacizumab
Control ArmEXPERIMENTALSIRT-Y90 + placebos (IV)

Interventions

NameTypeDescription
SIRT-Y90 with Atezolizumab + BevacizumabCOMBINATION_PRODUCTSingle 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.
SIRT-Y90 with Placebo (IV)COMBINATION_PRODUCTSingle or two-staged delivery of SIRT-Y90 (4 to 6 weeks), followed by placebo at every 3 weeks for 18 months.
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Eligibility Criteria

Age Range21 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: Patients must fulfill all of the following criteria to be eligible for this study: 1. Unequivocal diagnosis of HCC (AASLD 2010 diagnostic criteria or histology) that is locally advanced without extra-hepatic metastases but with significant tumor burden, i.e., * Tumor confin...

Countries:ChinaSingaporeSouth KoreaTaiwan
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