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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06558227
Enrollment
90
Registered
2024-08-16
Start date
2024-10-24
Completion date
2026-10-31
Last updated
2024-12-16

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

Conditions

Hepatocellular Carcinoma

Brief summary

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.

Interventions

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

BIOLOGICALBevacizumab

15 mg/kg administered intravenously Q3w

BIOLOGICALSintilimab

200 mg administered intravenously Q3w

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
progression free survival,PFSthrough study completion, up to 2 yeardefined as the time from receiving treatment until disease progression or death from any cause, whichever happens first.

Countries

China

Contacts

Primary ContactBo Liu
liub@zelgen.com+86-021-5838-2983

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026