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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07813572

Enrollment

600

Registered

2026-09-10

Start date

2026-09-01

Completion date

2032-09-01

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief summary

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

Interventions

DRUGZG005 for Injection

Participants receive ZG005 20 mg/kg IV, Q3W

DRUGBevacizumab ( Avastin)

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

DRUGSintilimab

Participants receive Sintilimab 200mg IV, Q3W

DRUGBevacizumab

Participants receive Bevacizumab 15 mg/kg IV, Q3W

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival (PFS)	up to 3 years	PFS evaluated by the Blinded Independent Review Committee (IRC) based on RECIST V1.1
Overall survival (OS)	up to 5 years	—

Secondary

Measure	Time frame	Description
PFS	up to 3 years	PFS evaluated by investigator based on RECIST V1.1
Objective response rate (ORR)	up to 3 years	ORR evaluated by IRC based on RECIST V1.1

Countries

China

Contacts

CONTACTWei Chen

weic@zelgen.com+86-0512-57309965

STUDY_DIRECTORJason Wu

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026