NCT07357636 Longitudinal Cohort Study of Immune-Related Adverse Events in Solid Tumor Patients Treated With Immune Checkpoint Inhibitors
| NCT ID | NCT07357636 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shantou University Medical College |
| Condition | Solid Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 940 participants |
| Start Date | 2019-01-10 |
| Primary Completion | 2029-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 940 participants in total. It began in 2019-01-10 with a primary completion date of 2029-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07357636 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07357636 currently recruiting?
Yes, NCT07357636 is actively recruiting participants. Contact the research team at myf61872169@163.com for enrollment information.
Where is the NCT07357636 trial being conducted?
This trial is being conducted at Fuzhou, China, Guangzhou, China, Sanya, China, Shantou, China and 2 additional locations.
Who is sponsoring the NCT07357636 clinical trial?
NCT07357636 is sponsored by Shantou University Medical College. The trial plans to enroll 940 participants.