Lung CancerNCT05326906
The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis
An observational study of Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
Immune checkpoint inhibitors have revolutionized lung cancer (LC) treatment, demonstrating a significant improvement in overall survival. However high-grade immune-related adverse events (irAEs) may result in harmful and serious clinical outcomes, even death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- PD-1/PD-L1 inhibitors
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with immuntherapy underwent severe Immune-related Hepatitis
Who may be able to join
- The lung cancers were diagnosed by pathological evaluation.
- The PD-1/PD-L1 inhibitors were administered in all patients.
- Grade 3-5 immune-related hepatitis had occurred.
- The pre-treatment tissues or peripheral blood were available.
Who cannot join
- The pathological type was not lung cancers.
- Grade 1-2 immune-related hepatitis would be excluded.
- The any-grade hepatitis were induced by chemotherapy or virus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis in Lung Cancer
Immune checkpoint inhibitors have revolutionized lung cancer (LC) treatment, demonstrating a significant improvement in overall survival. However high-grade immune-related adverse events (irAEs) may result in harmful and serious clinical outcomes, even death. Immune-related hepatitis (IRH) is a potentially serious complication of checkpoint blockade, with an incidence of 5%-10% for ICIs monotherapy, including 1%-2% with grade 3 or higher. Therefore, it is particularly important to explore new and better prognostic and predictive biomarkers for IRH.
- Conditions
- Lung Cancer
- Being tested
- PD-1/PD-L1 inhibitors
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1/PD-L1 inhibitorsDrug
PD-1/PD-L1 inhibitors (the dosage calculation according to dosing instructions)
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Immune-Related Hepatitis
Number of participants with Grade 3-4 IRH graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Measured: 2 years
Number of Participants Deaths
Number of participants with Grade 3-4 immune-related hepatitis by CTCAE 4.0 who still died after the corticosteroid (2mg/kg) and/or mycophenolate mofetil treatment.
Measured: 2 years
Secondary outcomes (1)
Number of Participants with Laboratory Abnormalities in Liver Tests
Number of participants with laboratory liver tests based on Hunan Cancer hospital to determine the safety of immunotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: ALT or AST >5-20 ULN, and > 20 x ULN;Total bilirubin > 3-10 ULN and > 10 x ULN
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 May 2018
- Primary completion1 May 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326906
- Sponsor's protocol ID
- STEM
- Status last verified
- May 2022
- First submitted
- 24 Mar 2022
- Last updated
- 16 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis in Lung Cancer
- ClinicalTrials.gov ID
- NCT05326906
- Acronym / sponsor ID
- STEM
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 14 Apr 2022 (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.
Immune checkpoint inhibitors have revolutionized lung cancer (LC) treatment, demonstrating a significant improvement in overall survival. However high-grade immune-related adverse events (irAEs) may result in harmful and serious clinical outcomes, even death. Immune-related hepatitis (IRH) is a potentially serious complication of checkpoint blockade, with an incidence of 5%-10% for ICIs monotherapy, including 1%-2% with grade 3 or higher. Therefore, it is particularly important to explore new and better prognostic and predictive biomarkers for IRH.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with immuntherapy underwent severe Immune-related Hepatitis
Key inclusion criteria (4 listed)
- The lung cancers were diagnosed by pathological evaluation.
- The PD-1/PD-L1 inhibitors were administered in all patients.
- Grade 3-5 immune-related hepatitis had occurred.
- The pre-treatment tissues or peripheral blood were available.
Key exclusion criteria (3 listed)
- The pathological type was not lung cancers.
- Grade 1-2 immune-related hepatitis would be excluded.
- The any-grade hepatitis were induced by chemotherapy or virus.
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 |
|---|---|---|
| PD-1/PD-L1 inhibitorsPD-1/PD-L1 inhibitors (the dosage calculation according to dosing instructions) | Drug | – |
Primary outcome
Number of Participants with Immune-Related Hepatitis
Time frame: 2 years
Number of participants with Grade 3-4 IRH graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Number of Participants Deaths
Time frame: 2 years
Number of participants with Grade 3-4 immune-related hepatitis by CTCAE 4.0 who still died after the corticosteroid (2mg/kg) and/or mycophenolate mofetil treatment.
1 secondary outcome
Number of Participants with Laboratory Abnormalities in Liver Tests
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Cancer, run by Hunan Province Tumor Hospital 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 16 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Immune-Related Hepatitis (time frame: 2 years). The study lists 2 primary outcomes in all. 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 16 May 2022.