A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
A prospective, multicenter, observational cohort study assessing the efficacy and safety of radiotherapy-sensitized immunotherapy in advanced breast cancer.
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
- •Subjects are eligible for inclusion in the study only if all the following criteria apply:
- •Men or women who are 18 years of age or older on the day of signing the informed consent;
- •Patients with advanced breast cancer that is inoperable or has metastasized, confirmed by histology or cytology;
- •Patients who, after MDT discussion at the metastatic breast cancer stage, are considered suitable for radiotherapy and have completed radiotherapy;
- •Patients who have previously received and continue to use immunotherapy, or are planned to receive immunotherapy, and are scheduled to receive a systemic treatment regimen including immunotherapy as chosen by the physician within 3 weeks after completing radiotherapy;
- •Patients with a traceable medical history during treatment;
- •Subjects who are able to sign an informed consent to participate in the study.
排除标准
- •Subjects with brain metastases or leptomeningeal metastases; if there are any suspected symptoms or signs of CNS involvement, they should be excluded by a cranial MRI scan;
- •Have not signed the informed consent form;
- •Pregnant or lactating women;
- •Other conditions deemed unsuitable for inclusion in the study by the investigator.
结局指标
主要结局
Progression-Free Survival
时间窗: 24 months
According to RECIST 1.1 criteria：Disease Progression (PD): Referring to the smallest sum of the diameters of all measured target lesions throughout the entire experimental study, there is a relative increase of at least 20% in the sum of the diameters (if the baseline measurement is the smallest, then the baseline value is used as the reference); in addition, there must be an absolute increase of at least 5 mm in the sum of the diameters (the appearance of one or more new lesions is also considered disease progression).
次要结局
未报告次要终点
研究者
Ma Fei，MD
Deputy Director of the Department of Medical Oncology
Cancer Institute and Hospital, Chinese Academy of Medical Sciences