Liver Injury Clinical Trial
Official title:
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
NCT number | NCT06402981 |
Other study ID # | IIT20240464A |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2020 |
Est. completion date | June 2025 |
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.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Lung cancer patients who have received at least one and more PD-1/PD-L1 inhibitor treatments; 2. Gender is not limited, age 18-80 years old Exclusion Criteria: 1. Severe liver injury prior to immunotherapy (elevation of transaminases, alkaline phosphatase, and glutamyl aminotransferase more than 5 times the upper limit of normal). 2. Patients who, in the opinion of the investigator, are not suitable for participation in the study. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | liver injury | The occurrence of immunosuppressant-associated liver damage was determined according to criteria set by the Common Terminology Criteria for Adverse Events (CTCAE 5.0). | 8 weeks |
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