Immune-Related Adverse Events After Cancer Immunotherapy and Safety of Treatment Rechallenge
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence and Clinical Characteristics of Immune-Related Adverse Events During ICI Therapy
研究概览
简要总结
This observational study aims to comprehensively characterize immune-related adverse events (irAEs) occurring during immune checkpoint inhibitor (ICI) therapy in cancer patients and to evaluate the safety and clinical outcomes of ICI rechallenge following irAE resolution.
In addition to detailed clinical data collection, the study incorporates biospecimen acquisition, when clinically indicated and feasible, including peripheral blood and organ-specific specimens (e.g., bronchoalveolar lavage fluid for ICI-related pneumonitis, liver biopsy tissue for ICI-related hepatitis, and other relevant clinical specimens). These samples will support exploratory immunologic and molecular analyses to better understand mechanisms underlying irAE development, resolution, and recurrence after rechallenge.
This study is designed to generate real-world evidence to improve risk stratification, toxicity management, and decision-making regarding immunotherapy continuation or re-initiation.
详细描述
- Background Immune checkpoint inhibitors (ICIs), including anti-PD-1, anti-PD-L1, and anti-CTLA-4 agents, have significantly improved survival outcomes across multiple malignancies. However, immune-related adverse events (irAEs), resulting from immune activation, frequently occur during ICI therapy and may involve multiple organ systems, including but not limited to the lung, liver, gastrointestinal tract, endocrine organs, heart, and other tissues.
irAEs range in severity from mild to life-threatening and often require treatment interruption, immunosuppressive therapy, or permanent discontinuation of ICIs. Although clinical guidelines provide general management recommendations, substantial heterogeneity exists in irAE presentation, clinical course, recovery patterns, and long-term outcomes.
In selected patients, re-initiation of ICIs after irAE resolution or stabilization is considered in clinical practice to maintain anti-tumor benefit. However, the recurrence risk, severity of recurrent irAEs, and associated clinical outcomes following ICI rechallenge remain incompletely defined. Additionally, the immunologic and tissue-level mechanisms underlying irAE development, resolution, and recurrence are not fully understood. 2. Study Objectives
This observational cohort study aims to:
① Characterize the incidence, timing, organ involvement, severity (according to CTCAE criteria), management strategies, and clinical outcomes of irAEs occurring during ICI therapy in cancer patients.
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
- •Adults (≥18 years old) with a diagnosis of malignant tumor.
- •Received treatment with immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, and/or anti-CTLA-4 agents).
- •Developed documented immune-related adverse events (irAEs) during ICI therapy, as determined by treating physicians.
- •Availability of clinical data for evaluation of irAE characteristics and outcomes.
排除标准
- •Patients receiving ICIs outside of the participating institution without accessible clinical records.
- •Insufficient clinical information to determine irAE diagnosis or outcomes.
- •Patients who decline use of their clinical data or biospecimens, when applicable.
研究组 & 干预措施
Patients With Immune-Related Adverse Events After Cancer Immunotherapy
干预措施: Immune Checkpoint Inhibitors (Drug)
结局指标
主要结局
Incidence and Clinical Characteristics of Immune-Related Adverse Events During ICI Therapy
时间窗: From initiation of ICI therapy through last follow-up (up to 24 months)
To evaluate the incidence, organ involvement, severity (CTCAE grading), timing of onset, and management patterns of immune-related adverse events occurring during immune checkpoint inhibitor therapy.
次要结局
未报告次要终点