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

NCT05675111 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12408

Last updated 2023-01-09

No results posted yet for this study

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.

Conditions

  • Immune Checkpoint Inhibitor
  • Endocrine Toxicity

Sponsors & Collaborators

  • Nanjing Medical University

    lead OTHER

Principal Investigators

  • Tao Yang, MD/PhD · First Affiliated Hospital, Nanjing Medical University

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2022-03-31
Completion
2022-10-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05675111 on ClinicalTrials.gov