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

Nanjing Medical University

Status: Completed

Conditions: Immune Checkpoint Inhibitor; Endocrine Toxicity

Study type: Observational

Funder types: Other

Identifiers

NCT05675111

2020-SR-544.A1

Details and patient eligibility

About

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.

Enrollment: 12,408 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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

Trial design

12,408 participants in 5 patient groups

Nanjing

Description:

The First Affiliated Hospital of Nanjing Medical University

Zhengzhou

Description:

Henan Provincial People's Hospital

Qingdao

Description:

The Affiliated Hospital of Qingdao University

Urumqi

Description:

People' s Hospital of Xinjiang Uygur Autonomous Region

Jinan

Description:

Shandong Provincial Hospital Affiliated to Shandong First Medical University