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

Zelgen Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Biological: ZG005 for Injection; Biological: Bevacizumab; Biological: Sintilimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06558227

ZG005-005

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Group A

Experimental group

Description:

ZG005 10 mg/kg administered intravenously every 3 weeks (Q3w) + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w

Treatment:

Biological: Bevacizumab

Biological: Bevacizumab

Biological: ZG005 for Injection

Group B

Experimental group

Description:

ZG005 20 mg/kg administered intravenously Q3w + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w

Treatment:

Biological: Bevacizumab

Biological: Bevacizumab

Biological: ZG005 for Injection

Group C

Experimental group

Description:

Sintilimab 200 mg administered intravenously Q3w + Bevacizumab (达攸同®) 15 mg/kg administered intravenously Q3w

Treatment:

Biological: Bevacizumab

Biological: Bevacizumab

Biological: Sintilimab