Immune Checkpoint InhibitorsNCT06402981
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
An observational study of Immune Checkpoint Inhibitors and Liver Injury, run by Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Checkpoint Inhibitors, Liver Injury
- What is being tested?
- High risk prediction model for liver injury
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients treated with PD-1/PD-L1 inhibitors
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
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.
Read the detailed description
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.
- Conditions
- Immune Checkpoint Inhibitors, Liver Injury
- Being tested
- High risk prediction model for liver injury
- Keywords
- PD-1/PD-L1 inhibitor, lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High risk prediction model for liver injuryOther
Risk Prediction Model for Liver Injury After Use of PD-1/PD-L1 Inhibitors
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: High risk prediction model for liver injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Jan 2020
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint InhibitorsStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiajia Chen, Zhejiang University
- Investigators
- Jiajia Chen, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402981
- Sponsor's protocol ID
- IIT20240464A
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06402981
- Acronym / sponsor ID
- IIT20240464A
- Conditions
- Immune Checkpoint Inhibitors, Liver Injury
- Keywords
- PD-1/PD-L1 inhibitor, lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liver damage group | – | Other: High risk prediction model for liver injuryLung 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 | – | Other: High risk prediction model for liver injuryLung 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients treated with PD-1/PD-L1 inhibitors
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High risk prediction model for liver injuryRisk Prediction Model for Liver Injury After Use of PD-1/PD-L1 Inhibitors | Other | No liver damage group, liver damage group |
Primary outcome
liver injury
Time frame: 8 weeks
The occurrence of immunosuppressant-associated liver damage was determined according to criteria set by the Common Terminology Criteria for Adverse Events (CTCAE 5.0).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiajia Chen principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Checkpoint Inhibitors and Liver Injury, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiajia Chen (+8615967109232, Jiajiatale0@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver injury (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.