A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma
NCT ID: NCT06233994
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2024-01-31
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ZG005+Donafenib
Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit.
ZG005 Powder for Injection
ZG005 will be administered at a dose of 10 mg/kg by intravenous (IV) infusion, once every 3 weeks (Q3W).
Donafenib Tosilate Tablets
Donafenib will be administered at a dose of 0.2 g by orally, Bis in die(Bid).
ZG005+Bevacizumab
Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit.
ZG005 Powder for Injection
ZG005 will be administered at a dose of 10 mg/kg by intravenous (IV) infusion, once every 3 weeks (Q3W).
Bevacizumab
Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion, once every 3 weeks (Q3W).
Interventions
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ZG005 Powder for Injection
ZG005 will be administered at a dose of 10 mg/kg by intravenous (IV) infusion, once every 3 weeks (Q3W).
Donafenib Tosilate Tablets
Donafenib will be administered at a dose of 0.2 g by orally, Bis in die(Bid).
Bevacizumab
Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion, once every 3 weeks (Q3W).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patients were deemed unsuitable for participating in the studyl by the investigator for any reasons.
18 Years
ALL
No
Sponsors
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Changsha Taihe Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Xiaoli Chai
Role: PRINCIPAL_INVESTIGATOR
Changsha Taihe Hospital
Locations
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Changsha Taihe Hospital
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Xiaoli Chai
Role: primary
Other Identifiers
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ZG005-IIT-001
Identifier Type: -
Identifier Source: org_study_id