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NCT05675111 Clinical Trial

Immune Checkpoint Inhibitors(ICPis)-Induced Endocrine Immune-related Adverse Events (irAEs)

Immune Checkpoint Inhibitor Clinical Trial

Official title:
Endocrine-related Adverse Events Caused by Immune Checkpoint Inhibitors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05675111
Other study ID # 2020-SR-544.A1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date October 30, 2022

Study information
Verified date January 2023
Source Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Immune checkpoint inhibitor (ICI) includes agents that block cytotoxic T-cell-associated antigen 4 (CTLA-4), programmed cell death protein 1 (PD-1), and programmed cell death protein ligand 1 (PD-L1). Since the FDA-approval of the CTLA-4 inhibitor ipilimumab in 2011, ICI drugs have emerged as a powerful new tool in the treatment for several advanced cancers. Now indications for ICI have expanded dramatically due to their efficacy and include a wide array of cancer types. However, the administration of ICI, whereas, carry the risk of developing immune-related adverse events (irAEs) and may lead to serious and even fatal events. Endocrine dysfunctions are among the most common irAEs that have been reported in clinical trials with ICI, including thyroid dysfunction, hypopituitarism, primary adrenal insufficiency (PAI) and insulin-deficient diabetes (ICI-DM). However, it is difficult to acquire a complete picture of irAEs from randomized controlled trials (RCTs) due to limitations in the study design and realistic practicalities.

Recruitment information / eligibility
Status Completed
Enrollment 12408
Est. completion date October 30, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 88 Years
Eligibility Inclusion Criteria: - Cancer patients who received one dose or more of PD-1/PD-L1 inhibitors Exclusion Criteria: - Insufficient reported details - Patients younger than 18 years old - in a double-blind study where treatment allocation cannot be resolved

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China First Affiliated Hospital, Nanjing Medical University Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary irAEs Immune Checkpoint Inhibitors Induced Endocrine Immune related Adverse Events through study completion, an average of 2 year
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