NCT07357636

Longitudinal Cohort Study of Immune-Related Adverse Events in Solid Tumor Patients Treated With Immune Checkpoint Inhibitors

Recruiting now Last updated 28 January 2026

What this trial tests

trial in Solid Tumor in 940 participants. Currently enrolling.

Timeline

10 January 2019

Primary endpoint
10 September 2029

10 September 2029

Quick facts

Lead sponsor	Shantou University Medical College
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	940
Start date	10 January 2019
Primary completion	10 September 2029
Estimated completion	10 September 2029
Sites	6 locations across China

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →
• Immune-Related Adverse Events — all drugs for Immune-Related Adverse Events →
• Immunotherapy Toxicity — all drugs for Immunotherapy Toxicity →

Sponsor

Shantou University Medical College

Who can join

18 and older, any sex, with Solid Tumor or Immune-Related Adverse Events. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Immune checkpoint inhibitors (ICIs) have transformed the treatment of solid tumors but are associated with immune-related adverse events (irAEs) that can affect virtually any organ system. While many irAEs are well recognized, neurological, neurocognitive, and psychiatric toxicities remain diagnostically challenging, potentially severe, and poorly understood, with limited predictive biomarkers.

This prospective longitudinal observational cohort study enrolls adult patients with solid tumors initiating a new course of ICI therapy. Participants undergo standardized baseline clinical assessments and biospecimen collection prior to ICI initiation, followed by longitudinal follow-up and event-driven sampling. Patients are dynamically assigned to organ-specific irAE cohorts based on the first clinically significant irAE that dictates management. Patients without grade ≥2 irAEs during follow-up serve as a comparator control cohort.

The primary objective is to characterize longitudinal immune and inflammatory biomarker trajectories associated with the development of irAEs and to identify predictive and prognostic biomarkers, with particular emphasis on neurological, neurocognitive, and psychiatric toxicities. Integrated clinical, imaging, and multi-omics data will be used to elucidate mechanisms of toxicity and inform future risk stratification and personalized management strategies.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. IL-6 receptor blockade impedes proinflammatory atypical Treg subset associated with immune checkpoint inhibitor-induced inflammatory arthritis.
   Ma Y, Liu N, Li Y, Zhang D, et al · · 2026 · cited 1× · PMID 42118587 · DOI 10.1172/jci200135