Tracking immune-related side effects in people with solid tumors starting immunotherapy

Longitudinal Cohort Study of Immune-Related Adverse Events in Solid Tumor Patients Receiving Immune Checkpoint Inhibitors, With Deep Phenotyping and Multi-Omics Biomarker Discovery

We will follow adults with solid tumors beginning immune checkpoint inhibitors to see if blood, tissue, and other tests can predict or explain immune-related side effects, with special attention to neurological problems.

Quick facts

• Study type: Observational
• Enrollment: 940 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shantou University Medical College (Academic / other)
• Drugs / interventions: prednisone
• Locations: 6 sites (Fuzhou, Fujian and 5 other locations)
• Trial ID: NCT07357636 on ClinicalTrials.gov

What this trial studies

Adults with histologically confirmed solid tumors who are about to start a new immune checkpoint inhibitor regimen are enrolled before their first dose and complete standardized baseline clinical assessments and biospecimen collection. Participants are followed longitudinally with scheduled visits and event-driven sampling at the time of suspected immune-related adverse events (irAEs). Patients are assigned to organ-specific cohorts based on the first clinically significant (grade ≥2) irAE that dictates management, while those without significant irAEs serve as controls. Deep phenotyping and multi-omics analyses, including immune cell profiling, proteomics, metabolomics, and microbiome studies, are used to identify biomarkers linked to irAE risk, severity, and outcomes.

Who should consider this trial

Good fit: Adults (age ≥18) with a confirmed solid tumor who plan to start a new immune checkpoint inhibitor regimen, can provide informed consent, complete baseline assessments before the first dose, and have available archival tumor tissue or agree to biopsy are ideal candidates.

Not a fit: Patients with prior solid organ or allogeneic stem cell transplants, those on chronic systemic immunosuppression above 10 mg/day prednisone equivalent, or those with uncontrolled medical or psychiatric issues that prevent follow-up are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, this work could help doctors predict who is at higher risk for serious immune-related side effects and guide earlier, more personalized management to reduce harm.

How similar studies have performed: Previous observational and biomarker studies have identified immune signatures for some common irAEs, but neurological and neurocognitive toxicities remain uncommon and poorly characterized, so this approach is partly novel.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years
* Histologically confirmed solid malignancy
* Planned initiation of a new immune checkpoint inhibitor regimen (monotherapy or combination) as standard of care or on an approved clinical trial
* Ability to provide informed consent
* Baseline study assessments and biospecimen collection completed prior to first ICI dose
* Life expectancy of at least 6 months as determined by treating oncologist
* Availability of archival tumor tissue or willingness to undergo biopsy if archival tissue is unavailable

Exclusion Criteria:

* Uncontrolled medical, psychiatric, or social conditions that would interfere with study participation or data interpretation
* Chronic systemic immunosuppression exceeding 10 mg/day prednisone equivalent within 14 days prior to enrollment (excluding inhaled, topical, or physiologic replacement doses)
* Prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation
* Untreated, symptomatic, or progressing brain metastases (treated and stable brain metastases allowed if off systemic steroids for at least 7 days)
* Inability or unwillingness to provide required baseline biospecimens

Where this trial is running

Fuzhou, Fujian and 5 other locations

• First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, China (Recruiting)
• Hainan Hospital of Chinese PLA General Hospital — Sanya, China (Recruiting)
• Affiliated Cancer Hospital of Shantou University Medical College — Shantou, China (Recruiting)
• the First Affiliated Hospital of Shantou University Medical College — Shantou, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Recruiting)

Study contacts

• Study coordinator: Yifei Ma, MD

Conditions Solid Tumor; Immune-Related Adverse Events; Immunotherapy Toxicity; Immune checkpoint inhibitors; Immunotherapy; Biomarkers; Neurotoxicity; Neuroimmune adverse events