NCT07434518招募中不适用
A Real-world Study on the Efficacy and Safety of Adebrelimab in the Treatment of Advanced-stage Small Cell Lung Cancer
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年1月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Immune-related adverse events
研究概览
简要总结
The goal of this observational study is to evaluate the safety and efficacy of adebrelimab in the perioperative and advanced-stage treatment of small cell lung cancer （SCLC） under real-world conditions. The main questions it aims to answer are:
- The safety of adebrelimab treatment in patients with advanced SCLC under real-world conditions, with a specific focus on the incidence of grade ≥3 immune-related adverse events. Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
- Observe and evaluate the efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Additionally, the study seeks to further explore the impact of patient baseline characteristics, such as brain metastases or liver metastases, and biomarkers on prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed extensive-stage small cell lung cancer;
- •Age ≥ 18 years;
- •The investigator determines that the patient is eligible for or is already receiving adebrelimab treatment.
排除标准
- •Patients concurrently receiving other immune-modulating drugs or therapies;
- •Patients currently participating in other interventional studies;
- •Patients with concurrent other malignancies;
- •Patients with missing key study-related data.
结局指标
主要结局
Immune-related adverse events
时间窗: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
The incidence of grade ≥3 immune-related adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
次要结局
- Overall survival (OS)(From enrollment to the end of treatment at 12 months.)
- Progression-free survival (PFS)(From enrollment to the end of treatment at 12 months.])
- Objective response rate (ORR)(From enrollment to the end of treatment at 12 months.)
- Disease control rate (DCR)(From enrollment to the end of treatment at 12 months.)
- The density of immune cells in peripheral blood before and after treatment(From enrollment to the end of treatment at 90 days.)
- Incidence of Adverse Events(Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.)
- Incidence of Serious Adverse Events(Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.)
研究者
Zheng Ruan
Dr./Chief Physician, Thoracic Surgery
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (1)
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