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
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Jiajia Chen
Jiajiatale0@zju.edu.cn
+8615967109232
Time Frame
Start Date: 2020-01-01
Estimated Completion Date: 2025-06
Participants
Target number of participants: 2000
Treatments
liver damage group
Lung cancer patients using PD-1/PD-L1 inhibitors with hepatic injury as determined by the hepatic index criteria set by the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
No liver damage group
Lung cancer patients with PD-1/PD-L1 inhibitors who are judged not to have liver injury according to the liver index criteria set by the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Related Therapeutic Areas
Sponsors
Leads: Zhejiang University