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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| irAEs | Immune Checkpoint Inhibitors Induced Endocrine Immune related Adverse Events | through study completion, an average of 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Tao Yang, MD/PhD | First Affiliated Hospital, Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
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