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Trial Title:
Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma
NCT ID:
NCT06558227
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
ZG005 for Injection
Description:
10 mg/kg or 20 mg/kg administered intravenously Q3w
Arm group label:
Group A
Arm group label:
Group B
Other name:
ZG005
Intervention type:
Biological
Intervention name:
Bevacizumab
Description:
15 mg/kg administered intravenously Q3w
Arm group label:
Group A
Arm group label:
Group B
Other name:
Avastin
Intervention type:
Biological
Intervention name:
Sintilimab
Description:
200 mg administered intravenously Q3w
Arm group label:
Group C
Intervention type:
Biological
Intervention name:
Bevacizumab
Description:
15 mg/kg administered intravenously Q3w
Arm group label:
Group C
Other name:
达攸同
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Country:
China
Contact:
Last name:
Hong Wu
Start date:
September 2024
Completion date:
October 2026
Lead sponsor:
Agency:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Agency class:
Industry
Source:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06558227