RecruitingNCT06402981

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


Sponsor

Zhejiang University

Enrollment

2,000 participants

Start Date

Jan 1, 2020

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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.

Interventions

OTHERHigh risk prediction model for liver injury

Risk Prediction Model for Liver Injury After Use of PD-1/PD-L1 Inhibitors


Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06402981


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