Significance of Hepatic Biomarkers in the Evaluation of Response to Treatment and Prognosis in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- basal ALT blood concentration in lung cancer patients treated with ICI determined
研究概览
简要总结
Lung cancer is the leading cause of cancer death worldwide. The emergence of immune checkpoint inhibitors (ICIs) has revolutionized the treatment of lung cancer over the past 10 years. Nivolumab, ipilimumab, pembrolizumab, atezolizumab, and durvalumab have been successively approved in non-small cell lung cancer, small cell lung cancer, and pleural mesothelioma. Although the efficacy of ICIs is remarkable in some patients, the objective response rate is only about 20%. The development of predictive biomarkers for treatment response is essential. Non-invasive methods and easily accessible biomarkers at low cost are required.ICIs activate the immune system through the inhibition of checkpoints (PD-L1, PD-1). The immune system and the liver are interconnected and constantly interact through a complex regulatory system. Patients with lung cancer frequently suffer from liver damage, due to metastases, treatments or underlying pathologies. The objective of the study is to evaluate the clinical significance of key liver biomarkers (AST, ALT, PAL, GGT, bilirubin, PT) in patients with lung cancer treated with ICI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Inclusion criteria:
- •Age > 18 years
- •Patient with lung cancer of any histological type
- •Initiation of ICI therapy
- •Signed consent for the study
排除标准
- •Patient with previous ICI treatment
结局指标
主要结局
basal ALT blood concentration in lung cancer patients treated with ICI determined
时间窗: one year
To Identify baseline blood ALT concentration as a predictive liver biomarker of treatment response in lung cancer patients treated with ICI.
次要结局
未报告次要终点
