Skip to main content
OpenTrials
Completed

NCT Number: NCT05675111

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. irAEs

    Time frame: through study completion, an average of 2 year

    Immune Checkpoint Inhibitors Induced Endocrine Immune related Adverse Events

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

Endocrine-related Adverse Events Caused by Immune Checkpoint Inhibitors

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 9, 2023
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.