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Trial Title:
A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma
NCT ID:
NCT06233994
Condition:
Advanced Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Study type:
Interventional
Study phase:
N/A
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 Powder for Injection
Description:
ZG005 will be administered at a dose of 10 mg/kg by intravenous (IV) infusion, once every
3 weeks (Q3W).
Arm group label:
ZG005+Bevacizumab
Arm group label:
ZG005+Donafenib
Other name:
ZG005
Intervention type:
Drug
Intervention name:
Donafenib Tosilate Tablets
Description:
Donafenib will be administered at a dose of 0.2 g by orally, Bis in die(Bid).
Arm group label:
ZG005+Donafenib
Other name:
Donafenib
Intervention type:
Biological
Intervention name:
Bevacizumab
Description:
Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion, once every 3 weeks
(Q3W).
Arm group label:
ZG005+Bevacizumab
Summary:
This is a randomized, open-label study to evaluate the safety and efficacy of ZG005 in
combination with Donafenib or Bevacizumab in patients with advanced hepatocellular
carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female ≥18 years of age.
- Fully understand the study and voluntarily sign the informed consent form.
- Histologically or cytologically confirmed diagnosis of metastatic or unresectable
hepatocellular carcinoma (HCC).
- Life expectancy >= 3 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion Criteria:
- Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Patients were deemed unsuitable for participating in the studyl by the investigator
for any reasons.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Changsha Taihe Hospital
Address:
City:
Changsha
Country:
China
Contact:
Last name:
Xiaoli Chai
Start date:
January 2024
Completion date:
January 2026
Lead sponsor:
Agency:
Changsha Taihe Hospital
Agency class:
Other
Source:
Changsha Taihe Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06233994
