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NCT Number: NCT06558227

Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in 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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location status: Recruiting

Location contact

Hong Wu

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZG005 for Injection

Biological

10 mg/kg or 20 mg/kg administered intravenously Q3w

Other names: ZG005

Bevacizumab

Biological

15 mg/kg administered intravenously Q3w

Other names: Avastin

Sintilimab

Biological

200 mg administered intravenously Q3w

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Liu

CONTACT

[email protected]

+86-021-5838-2983

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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