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

Z

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)

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

Trial contacts and locations

1

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Central trial contact

Bo Liu

Data sourced from clinicaltrials.gov

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