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

Endocrine-related Adverse Events Caused by Immune Checkpoint Inhibitors

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.

Study Overview

• Status: Completed
• Conditions: Immune Checkpoint Inhibitor; Endocrine Toxicity

• Study Type: Observational
• Enrollment (Actual): 12408

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • First Affiliated Hospital, Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 years or older, with cancers who received one dose or more of PD-1/PD-L1 inhibitors 5 academic centers from June 2018 to March 2021 were included.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Nanjing; The First Affiliated Hospital of Nanjing Medical University
Zhengzhou; Henan Provincial People's Hospital
Qingdao; The Affiliated Hospital of Qingdao University
Urumqi; People' s Hospital of Xinjiang Uygur Autonomous Region
Jinan; Shandong Provincial Hospital Affiliated to Shandong First Medical University

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
irAEs	Immune Checkpoint Inhibitors Induced Endocrine Immune related Adverse Events	through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Investigators: Study Chair: Tao Yang, MD/PhD, First Affiliated Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: January 1, 2023
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Estimate): January 9, 2023

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2020-SR-544.A1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No