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NCT Number: NCT07813572

ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular

The purpose of the study is to evaluate the efficacy of ZG005 combined with bevacizumab compared with sintilimab combined with bevacizumab in the first-line treatment of participants with advanced HCC

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, China

Location contact

Shukui Qin

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with histologically/cytologically confirmed unresectable or metastatic advanced HCC;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.
  • At least one measurable lesion based on Recist1.1.
  • No prior systemic therapy for HCC.
  • Child-Pugh ≤6 , no history of hepatic encephalopathy.

Exclusion criteria

  • Active Central nervous system (CNS) metastasis or leptomeningeal metastases.
  • Any condition that is not suitable for participate in this study as determined by investigator.

Treatment and study plan

ZG005 for Injection

Drug

Participants receive ZG005 20 mg/kg IV, Q3W

Other names: ZG005

Bevacizumab ( Avastin)

Drug

Participants receive Bevacizumab ( Avastin) 15 mg/kg IV, Q3W

Sintilimab

Drug

Participants receive Sintilimab 200mg IV, Q3W

Bevacizumab

Drug

Participants receive Bevacizumab 15 mg/kg IV, Q3W

Other names: 达攸同

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: up to 3 years

    PFS evaluated by the Blinded Independent Review Committee (IRC) based on RECIST V1.1

  2. Overall survival (OS)

    Time frame: up to 5 years

Secondary outcomes

  1. PFS

    Time frame: up to 3 years

    PFS evaluated by investigator based on RECIST V1.1

  2. Objective response rate (ORR)

    Time frame: up to 3 years

    ORR evaluated by IRC based on RECIST V1.1

Study contacts

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

Wei Chen

CONTACT

[email protected]

+86-0512-57309965

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

A Phase 3, Randomized, Open-Label, Active-Controlled, Multicenter Study of ZG005 in Combination With Bevacizumab Versus Sintilimab in Combination With Bevacizumab in the First-Line Treatment of Advanced Hepatocellular Carcinoma

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

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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