Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402981
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-05-02
Brief Title:
A Clinical Study on the Analysis of Risk Factors for the Occurrence of PD-1PD-L1 Inhibitor-associated Liver Injury in Lung Cancer Patients
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
Official Title:
A Clinical Study on the Analysis of Risk Factors for the Occurrence of PD-1PD-L1 Inhibitor-associated Liver Injury in Lung Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to investigate the risk factors of PD-1PD-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-1PD-L1 Inhibitor-Related Liver Injury
Improving immunotherapy protocols for lung cancer patients
Exploring risk factors for liver injury
Constructing a Predictive Model for the Occurrence of Liver Injury in PD-1PD-L1 Inhibitor-Related Liver Injury
Improving immunotherapy protocols for lung cancer patients
Detailed Description:
PD-1PD-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-1PD-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-1PD-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-1PD-L1 inhibitors from 202001 to 202406 to investigate the risk factors of PD-1PD-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None