A Multicenter, Randomized, Open-label Phase II Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab for First-line Treatment of Advanced Hepatocellular Carcinoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- progression free survival，PFS
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Fully understand the study and voluntarily sign the informed consent form.
- •18-75 years of age;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1；
- •Life expectancy ≥ 12 weeks.
Exclusion Criteria
- •Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
Arms & Interventions
Group A
ZG005 10 mg/kg administered intravenously every 3 weeks (Q3w) + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w
Intervention: ZG005 for Injection (Biological)
Group A
ZG005 10 mg/kg administered intravenously every 3 weeks (Q3w) + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w
Intervention: Bevacizumab (Biological)
Group B
ZG005 20 mg/kg administered intravenously Q3w + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w
Intervention: ZG005 for Injection (Biological)
Group B
ZG005 20 mg/kg administered intravenously Q3w + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w
Intervention: Bevacizumab (Biological)
Group C
Sintilimab 200 mg administered intravenously Q3w + Bevacizumab (达攸同®) 15 mg/kg administered intravenously Q3w
Intervention: Sintilimab (Biological)
Group C
Sintilimab 200 mg administered intravenously Q3w + Bevacizumab (达攸同®) 15 mg/kg administered intravenously Q3w
Intervention: Bevacizumab (Biological)
Outcomes
Primary Outcomes
progression free survival，PFS
Time Frame: through study completion, up to 2 year
defined as the time from receiving treatment until disease progression or death from any cause, whichever happens first.
Secondary Outcomes
No secondary outcomes reported