Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma
Phase 2
Recruiting
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT06558227
- Lead Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C Sintilimab Sintilimab 200 mg administered intravenously Q3w + Bevacizumab (达攸同®) 15 mg/kg administered intravenously Q3w Group B ZG005 for Injection ZG005 20 mg/kg administered intravenously Q3w + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w Group A ZG005 for Injection ZG005 10 mg/kg administered intravenously every 3 weeks (Q3w) + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w Group A Bevacizumab ZG005 10 mg/kg administered intravenously every 3 weeks (Q3w) + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w Group B Bevacizumab ZG005 20 mg/kg administered intravenously Q3w + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w Group C Bevacizumab Sintilimab 200 mg administered intravenously Q3w + Bevacizumab (达攸同®) 15 mg/kg administered intravenously Q3w
- Primary Outcome Measures
Name Time Method progression free survival，PFS 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China