Clinical trial · Observational
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
NCT06402981CI-TRIAL-00076852unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immune Checkpoint Inhibitors | — | UNRESOLVED | — |
| Liver Injury | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High risk prediction model for liver injury | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- liver damage group
- description
- 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)
- interventionNames
- Other: High risk prediction model for liver injury
- label
- No liver damage group
- description
- 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)
- interventionNames
- Other: High risk prediction model for liver injury
Primary outcomes (1)
- measure
- liver injury
- timeFrame
- 8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.