Advanced Hepatocellular Carcinoma
Conditions
Brief 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.
Interventions
BIOLOGICALZG005 Powder for Injection
ZG005 will be administered at a dose of 10 mg/kg by intravenous (IV) infusion, once every 3 weeks (Q3W).
Donafenib will be administered at a dose of 0.2 g by orally, Bis in die(Bid).
BIOLOGICALBevacizumab
Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion, once every 3 weeks (Q3W).
Sponsors
Changsha Taihe Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | up to approximately 2 years | The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria. |
| Progression Free Survival (PFS) | up to approximately 2 years | Time from first dose of the investigational drug to PD or death from any cause. |
Countries
China
Contacts
Primary ContactYongsheng Chu
Outcome results
None listed