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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High risk prediction model for liver injury | Other | Risk Prediction Model for Liver Injury After Use of PD-1/PD-L1 Inhibitors |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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Lung cancer patients treated with PD-1/PD-L1 inhibitors
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiajia Chen | Contact | +8615967109232 | Jiajiatale0@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jiajia Chen | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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