Multicenter Observational Prospective Study of Immune Checkpoint Inhibitors in Patients With Solid Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This prospective, multicenter observational study included all patients with solid neoplasms who received treatment with immune checkpoint inhibitors (ICIs) in clinical practice, regardless of tumor type, tumor stage, type of immunotherapy, or treatment lines. This study aimed to assess the use, effectiveness, and safety of ICIs for solid neoplasms in real-world populations, which can provide insights into clinical decisions associated with the use of ICIs for the treatment of cancer patients in the real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age at least 18 years.
- •Pathologically confirmed diagnosis of a solid tumor cancer.
- •Patients receiving treatment with immune checkpoint inhibitors.
- •Ability to understand and willingness to provide the informed consent.
排除标准
- •Age < 18 years.
- •Patients with hematological malignancies or solid benign tumors.
- •Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
结局指标
主要结局
Overall Survival
时间窗: Three years
OS was defined as the time from the date of first administration of immunotherapy until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
次要结局
- Overall Objective Response Rate(At least 6 weeks after start of treatment)
- Progression Free Survival(Three years)
- Percentage of Participants With Adverse Events(Three years)