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

Sponsor
National Cancer Centre, Singapore
Study ID
NCT05377034
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
21 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • SIRT-Y90 with Atezolizumab + Bevacizumab — COMBINATION_PRODUCT
    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.
  • SIRT-Y90 with Placebo (IV) — COMBINATION_PRODUCT
    Single or two-staged delivery of SIRT-Y90 (4 to 6 weeks), followed by placebo at every 3 weeks for 18 months.

Study Details

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).

Key Dates

Start date
Oct 26, 2022
Status verified
Sep 2025
Primary completion
Jul 25, 2026
Completion
Jan 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study Arm
    SIRT-Y90 + 1200mg atezolizumab + 15mg/kg bevacizumab
  • Experimental: Control Arm
    SIRT-Y90 + placebos (IV)

Primary Outcome Measure

Best Overall Response Rate (BORR) at 9 months post-randomization. [ Time Frame: 9 months post-randomization. ]

Central Contacts

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