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临床试验/NCT06402981
NCT06402981招募中不适用

A Clinical Study on the Analysis of Risk Factors for the Occurrence of PD-1/PD-L1 Inhibitor-associated Liver Injury in Lung Cancer Patients

Zhejiang University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
liver injury

研究概览

简要总结

The goal of this observational study is to investigate the risk factors of PD-1/PD-L1 inhibitor-associated liver injury, to construct a prediction model for the occurrence of liver injury. The main questions it aims to answer are:

  • Exploring risk factors for liver injury.
  • Constructing a Predictive Model for the Occurrence of Liver Injury in PD-1/PD-L1 Inhibitor-Related Liver Injury.
  • Improving immunotherapy protocols for lung cancer patients.

详细描述

PD-1/PD-L1 inhibitors have achieved surprising results in lung cancer treatment and have been approved by the FDA for the treatment of different types of lung cancer. Their overall toxicity is lower than that of standard chemotherapy, but a number of immune-related adverse events have been reported clinically. Liver injury is one of the leading causes of death from adverse events due to PD-1/PD-L1 inhibitors. The occurrence of immune-related liver damage has an important impact on the tumor treatment and prognosis of patients. Most of the current domestic and international studies focus on the overall description and study of PD-1/PD-L1 antibody-related adverse events, and there is no definitive description of the risk factors for the development of immune-related liver injury in lung cancer patients. The aim of this project is to review the clinical data of lung cancer patients treated with PD-1/PD-L1 inhibitors from 2020.01 to 2024.06, to investigate the risk factors of PD-1/PD-L1 inhibitor-associated liver injury, to construct a prediction model for the occurrence of liver injury, and to take measures to prevent the occurrence of fatal immune liver injury, which is of great significance to the immunotherapy of clinical tumor patients. It is of great significance to the immunotherapy of clinical tumor patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Lung cancer patients who have received at least one and more PD-1/PD-L1 inhibitor treatments;
  • •Gender is not limited, age 18-80 years old

排除标准

  • •Severe liver injury prior to immunotherapy (elevation of transaminases, alkaline phosphatase, and glutamyl aminotransferase more than 5 times the upper limit of normal).
  • •Patients who, in the opinion of the investigator, are not suitable for participation in the study.

结局指标

主要结局

liver injury

时间窗: 8 weeks

The occurrence of immunosuppressant-associated liver damage was determined according to criteria set by the Common Terminology Criteria for Adverse Events (CTCAE 5.0).

次要结局

未报告次要终点

研究者

发起方
Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiajia Chen

Chief Physician of the First Affiliated Hospital,Zhejiang University School of Medicine

Zhejiang University

研究点 (1)

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