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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

NCT05377034 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-06

No results posted yet for this study

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).

Conditions

  • Locally Advanced Hepatocellular Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Sirtex Medical

    collaborator INDUSTRY

  • Singapore Clinical Research Institute

    collaborator OTHER

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Pierce CHOW, MD, PhD · National Cancer Centre, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2026-07-25
Completion
2028-01-31

Countries

  • China
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05377034 on ClinicalTrials.gov