An interventional study of Patients starting a treatment by ICI in Solid Tumor, sponsored by Institut Claudius Regaud. Completed at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Other
This trial is a multicentric, prospective cohort study of 150 patients aiming to model evolution of toxicity over time in patients with solid tumor and starting first cycle of Immune Checkpoint Inhibitor (ICI) treatment.
The study will be conducted on a population of patients treated with ICI in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre.
The study data (immune-related adverse events) will be collected during each administration of the treatment.
A questionnaire will be completed by the patient before the treatment administrations.
Patients will be followed until disease progression or up to 12 months of treatment.
Exclusion Criteria:
Other: Patients starting a treatment by ICI
Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30) before treatment administration and during the 12 months of treatment period, at the following time points: * every 6 weeks for treatment regimen administered every 2 or 3 weeks * at Weeks 6, 12, 20, 24 for treatment regimen administered every 4 weeks
Prevalence of toxicities evaluated according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03
Time frame: 12 months by patient
Time to appearance of toxicity
Time frame: 12 months by patient
Rate of patients for which treatment was restarted among those who had stopped treatment for the management of an immune-related Adverse Event (irAE)
Time frame: 12 months by patient
Quality of life using the QLQ-C30 questionnaire
Time frame: 12 months by patient
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Institut Claudius Regaud