Analyzing liver injury risks in lung cancer patients using PD-1/PD-L1 inhibitors
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
Zhejiang University · NCT06402981
This study is trying to find out what factors might increase the risk of liver injury in lung cancer patients who are being treated with PD-1/PD-L1 inhibitors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zhejiang University (other) |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06402981 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the risk factors associated with liver injury in lung cancer patients treated with PD-1/PD-L1 inhibitors. By reviewing clinical data from patients treated between January 2020 and June 2024, the study seeks to identify specific risk factors and construct a predictive model for liver injury occurrence. The findings could lead to improved immunotherapy protocols and better management of adverse effects related to these treatments. The study addresses a critical gap in understanding the safety profile of PD-1/PD-L1 inhibitors in this patient population.
Who should consider this trial
Good fit: Ideal candidates are lung cancer patients aged 18-80 who have received at least one PD-1/PD-L1 inhibitor treatment.
Not a fit: Patients with severe liver injury prior to immunotherapy or deemed unsuitable by the investigator may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and efficacy of immunotherapy for lung cancer patients by preventing liver injuries.
How similar studies have performed: While there have been studies on PD-1/PD-L1 inhibitors, this specific focus on liver injury risk factors is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Jiajia Chen — Zhejiang University
- Study coordinator: Jiajia Chen
- Email: Jiajiatale0@zju.edu.cn
- Phone: +8615967109232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Immune Checkpoint Inhibitors, Liver Injury, PD-1/PD-L1 inhibitor, lung cancer