Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study ID
NCT06558227
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ZG005 for Injection — BIOLOGICAL
    10 mg/kg or 20 mg/kg administered intravenously Q3w
  • Bevacizumab — BIOLOGICAL
    15 mg/kg administered intravenously Q3w
  • Sintilimab — BIOLOGICAL
    200 mg administered intravenously Q3w
  • Bevacizumab — BIOLOGICAL
    15 mg/kg administered intravenously Q3w

Study Details

This study is a randomized, open-label, positive-controlled, multicenter phase II clinical trial. It evaluates the efficacy and safety of ZG005 combined with Bevacizumab compared to Sintilimab combined with Bevacizumab in first-line treatment for patients with advanced hepatocellular carcinoma.

Key Dates

First listed
Aug 16, 2024
Start date
Oct 24, 2024
Status verified
Aug 2024
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

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

Arms

  • Experimental: Group A
    ZG005 10 mg/kg administered intravenously every 3 weeks (Q3w) + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w
  • Experimental: Group B
    ZG005 20 mg/kg administered intravenously Q3w + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w
  • Experimental: Group C
    Sintilimab 200 mg administered intravenously Q3w + Bevacizumab (达攸同®) 15 mg/kg administered intravenously Q3w

Primary Outcome Measure

progression free survival，PFS [ Time Frame: through study completion, up to 2 year ]

Central Contacts

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