Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy

Overview

To review cases from NTUH who developed endocrinopathy and metabolic diseases after immunotherapy, and statistically analyzed their age, clinical presentation, image findings, treatment and its response.

Full Title of Study: “Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy and Metabolic Diseases -a Case Series of Taiwanese Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: July 1, 2025

Detailed Description

Immune checkpoint blockade-based immunotherapy is a new modality of cancer treatment with a unique mechanism that has gained increased numbers of indication and is now used in several cancer types. However, immune-related adverse events (irAEs) emerge as a new entity of diseases involving one or multiple organ systems. irAEs could result in interruption of immunotherapy, morbidities of patients or even death. Among various manifestations of irAEs, endocrinopathy and metabolic diseases are rare but important, and require prompt diagnosis and treatment to avoid life-threatening conditions.

Thus, we intend to review cases from NTUH who developed endocrinopathy and metabolic diseases after immunotherapy, and statistically analyzed their age, clinical presentation, image findings, treatment and its response. We will also review literatures to evaluate the difference and similarity from previous diagnostic and treatment experience.

Interventions

  • Drug: Immunotherapy
    • Patients receive immunotherapy for cancer treatment

Arms, Groups and Cohorts

  • Patient with endocrinopathy after immunotherapy
    • Patient with endocrinopathy after immunotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Changes of endocrine profiles
    • Time Frame: 10 year
    • Changes of serum fT4 TSH Glucose A1C ACTH cortisol LH FSH estradiol progesterone GH IGF1 prolactin

Secondary Measures

  • Treatment response of the cancer after immunotherapy
    • Time Frame: 10 years
    • The changes of size and extent of the tumors

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who receive immunotherapy in NTUH and develop endocrinopathy after therapy

Exclusion Criteria

  • Patients less than 20 years old. Patients who are pregnant

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Taiwan University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shyang-Rong Shih, MD, PhD, Study Director, National Taiwan University Hospital
  • Overall Contact(s)
    • Shyang-Rong Shih, +886-972653337, srshih@ntu.edu.tw

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