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

NCT06402981 | Recruiting

• 1 other identifier: IIT20240464A
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immune Checkpoint Inhibitors; Liver Injury

Keywords

PD-1/PD-L1 inhibitor; lung cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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)

Other: High risk prediction model for liver injury

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)

Other: High risk prediction model for liver injury

Interventions

High risk prediction model for liver injury OTHER

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

No liver damage group; liver damage group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lung cancer patients treated with PD-1/PD-L1 inhibitors

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jiajia Chen

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiajia Chen

CONTACT

+8615967109232; Jiajiatale0@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of the First Affiliated Hospital,Zhejiang University School of Medicine

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: January 1, 2020
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)