A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib Tosilate Tablets or Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- •Patients were deemed unsuitable for participating in the studyl by the investigator for any reasons.
研究组 & 干预措施
ZG005+Donafenib
Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit.
干预措施: ZG005 Powder for Injection (Biological)
ZG005+Donafenib
Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit.
干预措施: Donafenib Tosilate Tablets (Drug)
ZG005+Bevacizumab
Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit.
干预措施: ZG005 Powder for Injection (Biological)
ZG005+Bevacizumab
Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit.
干预措施: Bevacizumab (Biological)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 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)
时间窗: up to approximately 2 years
Time from first dose of the investigational drug to PD or death from any cause.
次要结局
未报告次要终点