NCT07099547招募中2 期
A Study to Evaluate the Efficacy and Safety of ZG005 in Combination With Platinum-Based Chemotherapy as First-Line Treatment in Participants With Advanced Biliary Tract Carcinoma
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 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, phase II study evaluating first-line treatment for advanced gallbladder cancer. It aims to assess the efficacy, safety, pharmacokinetics, and immunogenicity of the ZG005 in Combination with gemcitabine and cisplatin as first-line therapy in Participants with advanced gallbladder cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand the study and voluntarily sign the informed consent form.
- •Subjects with a histopathological or cytologically diagnosis of Gallbladder cancer.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Life expectancy of at least 3 months.
排除标准
- •Participants were deemed unsuitable for participating in the study by the investigator for any reasons.
研究组 & 干预措施
Text group
Experimental
ZG005+Gemcitabine +Cisplatin
干预措施: ZG005 (Drug)
Text group
Experimental
ZG005+Gemcitabine +Cisplatin
干预措施: Gemcitabine (Drug)
Text group
Experimental
ZG005+Gemcitabine +Cisplatin
干预措施: Cisplatin (Drug)
Control group
Experimental
Tislelizumab+Gemcitabine+Cisplatin
干预措施: Tislelizumab (Drug)
Control group
Experimental
Tislelizumab+Gemcitabine+Cisplatin
干预措施: Gemcitabine (Drug)
Control group
Experimental
Tislelizumab+Gemcitabine+Cisplatin
干预措施: Cisplatin (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to 2 years
次要结局
- Adverse Events (AEs)(Up to 2 years)
研究者
研究点 (1)
Loading locations...
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