Status:
RECRUITING
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
Lead Sponsor:
Zhejiang University
Conditions:
Immune Checkpoint Inhibitors
Liver Injury
Eligibility:
All Genders
18-80 years
Brief 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 qu...
Detailed Description
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 t...
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06402981
Start Date
January 1 2020
End Date
June 1 2025
Last Update
May 7 2024
Active Locations (1)
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1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China