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

December 11, 2024 updated by: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Hong Wu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
ZG005 10 mg/kg administered intravenously every 3 weeks (Q3w) + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w
Biological: ZG005 for Injection
10 mg/kg or 20 mg/kg administered intravenously Q3w
Other Names:
  • ZG005
Biological: Bevacizumab
15 mg/kg administered intravenously Q3w
Other Names:
  • 达攸同
Experimental: Group B
ZG005 20 mg/kg administered intravenously Q3w + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w
Biological: ZG005 for Injection
10 mg/kg or 20 mg/kg administered intravenously Q3w
Other Names:
  • ZG005
Biological: Bevacizumab
15 mg/kg administered intravenously Q3w
Other Names:
  • 达攸同
Experimental: Group C
Sintilimab 200 mg administered intravenously Q3w + Bevacizumab (达攸同®) 15 mg/kg administered intravenously Q3w
Biological: Bevacizumab
15 mg/kg administered intravenously Q3w
Other Names:
  • 达攸同
Biological: Sintilimab
200 mg administered intravenously Q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, up to 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

  • Study Chair: Jason Wu, Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZG005-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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