Clinical trial · Observational
The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis
The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis in Lung Cancer
- 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)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1/PD-L1 inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Number of Participants with Immune-Related Hepatitis
- timeFrame
- 2 years
- description
- Number of participants with Grade 3-4 IRH graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0)
- measure
- Number of Participants Deaths
- timeFrame
- 2 years
- description
- 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.
Secondary outcomes (1)
- measure
- Number of Participants with Laboratory Abnormalities in Liver Tests
- timeFrame
- 2 years
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available