The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis in Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants Deaths
研究概览
简要总结
Immune checkpoint inhibitors have revolutionized lung cancer (LC) treatment, demonstrating a significant improvement in overall survival. However high-grade immune-related adverse events (irAEs) may result in harmful and serious clinical outcomes, even death. Immune-related hepatitis (IRH) is a potentially serious complication of checkpoint blockade, with an incidence of 5%-10% for ICIs monotherapy, including 1%-2% with grade 3 or higher. Therefore, it is particularly important to explore new and better prognostic and predictive biomarkers for IRH.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •The lung cancers were diagnosed by pathological evaluation.
- •The PD-1/PD-L1 inhibitors were administered in all patients.
- •Grade 3-5 immune-related hepatitis had occurred.
- •The pre-treatment tissues or peripheral blood were available.
排除标准
- •The pathological type was not lung cancers.
- •Grade 1-2 immune-related hepatitis would be excluded.
- •The any-grade hepatitis were induced by chemotherapy or virus.
结局指标
主要结局
Number of Participants Deaths
时间窗: 2 years
Number of participants with Grade 3-4 immune-related hepatitis by CTCAE 4.0 who still died after the corticosteroid (2mg/kg) and/or mycophenolate mofetil treatment.
Number of Participants with Immune-Related Hepatitis
时间窗: 2 years
Number of participants with Grade 3-4 IRH graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0)
次要结局
- Number of Participants with Laboratory Abnormalities in Liver Tests(2 years)
研究者
Yongchang Zhang
Director, Head of Medical Oncology, Principal Investigator, Clinical Professor
Hunan Province Tumor Hospital