NCT05862259招募中不适用
A Multicenter, Multiomics, Non-interventional, Real-world Study of the Efficacy and Safety of Immune Checkpoint Inhibitors as First-line Therapy for Advanced Malignancies
Xinqiao Hospital of Chongqing1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年8月10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
- 120
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
In this study, we collected the data of immunohistochemistry, gene detection, image, OS, PFS, Orr, and so on. Secondly, the database of immunotherapy for malignant tumor was established, and the predictive model was constructed to verify and establish the rationality and validity of the biomarkers and predictive system of immunotherapy
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent has been signed and, in the judgment of the investigator, the patient is able to comply with the study protocol and sign a written informed consent.
- •the advanced malignant tumors (solid tumors of the non-small-cell lung carcinoma, stomach, breast, urinary system, etc.) were diagnosed by histopathology.
- •the stage IV according to the eighth edition of IASLC.
- •PS 0-2, the expected survival > 3 months.
- •the age of 18-75 years.
- •no contraindication to treatment with immune checkpoint inhibitors.
排除标准
- •the patients' compliance was poor, which violated the rules of the trial;
- •the patients with severe dysfunction of vital organs (heart, liver and kidney) ;
- •the patients with other malignant tumors;
- •the researchers considered that the patients should not participate in other conditions of the trial.
结局指标
主要结局
Progression-free survival
时间窗: six months
The time between randomization and the first occurrence of disease progression or death from any cause
次要结局
- Objective response rate(one years)
- Overall survival(two years)
- Immune-Related Adverse Events(two years)
研究者
Jianguo Sun
Deputy director of oncology department，clinical professor
Xinqiao Hospital of Chongqing
研究点 (1)
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