The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis

NCT05326906 | Completed

• 1 other identifier: STEM
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  2 years

Secondary Outcomes (1)

• Number of Participants with Laboratory Abnormalities in Liver Tests

  2 years

Interventions

PD-1/PD-L1 inhibitors DRUG

PD-1/PD-L1 inhibitors (the dosage calculation according to dosing instructions)

Eligibility Criteria

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

Study Population

Patients with immuntherapy underwent severe Immune-related Hepatitis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissue sample and blood

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 14, 2022
• Study Start: May 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-05

Locations

CN (1)