NCT07547787招募中不适用
An Extension Study for Collecting Long-term Follow-up Data of Subjects Enrolled in Clinical Trials of Cadonilimab (AK104)
Akeso1 个研究点 分布在 1 个国家目标入组 610 人开始时间: 2024年12月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 610
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is an observational and non-interventional clinical study that only collects long-term follow-up data of the subjects. As the world's first approved PD-1/CTLA-4 bispecific antibody for marketing, Cadonilimab may confer long-term survival benefits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
- •Subjects have received prior systemic therapy in sponsor-initiated clinical trials of cadonilimab (AK104), and this extension study is conducted after the completion of the original trial.
- •Agree to proceed with the extended follow-up procedures.
- •This is an observational and non-interventional clinical study, in which subjects are allowed to participate in other clinical studies at the same time.
排除标准
- 未提供
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 5 years
OS is defined as the time from randomization to death due to any cause.
次要结局
未报告次要终点
研究者
研究点 (1)
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