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
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hepatocellular-carcinoma
Started Oct 2024
Shorter than P25 for phase_2 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2024
CompletedFirst Posted
Study publicly available on registry
August 16, 2024
CompletedStudy Start
First participant enrolled
October 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
December 16, 2024
August 1, 2024
1.9 years
August 14, 2024
December 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
progression free survival，PFS
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
Study Arms (3)
Group A
EXPERIMENTALZG005 10 mg/kg administered intravenously every 3 weeks (Q3w) + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w
Group B
EXPERIMENTALZG005 20 mg/kg administered intravenously Q3w + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w
Group C
EXPERIMENTALSintilimab 200 mg administered intravenously Q3w + Bevacizumab (达攸同®) 15 mg/kg administered intravenously Q3w
Interventions
10 mg/kg or 20 mg/kg administered intravenously Q3w
Eligibility Criteria
You may qualify if:
- Fully understand the study and voluntarily sign the informed consent form.
- years of age;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1；
- Life expectancy ≥ 12 weeks.
You may not qualify if:
- Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Hospital of Sichuan University
Chengdu, Sichuan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jason Wu
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2024
First Posted
August 16, 2024
Study Start
October 24, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
December 16, 2024
Record last verified: 2024-08