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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: myf61872169@163.com
• Phone: 8618883852716

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.