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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Immune Checkpoint Inhibitor

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