Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Measurement of Epidermal Growth Factor Receptor-EGFR-specific T cells (The method is based on the ELISPOT test. The technique measures secretion of cytokines related to the activation of cytotoxic T lymphocytes following stimulation of peripheral blood mononuclear cells with peptides derived from the antigen). Measurement time: 12 months.
Overall survival (Time from recruitment until death from any cause). Measurement time: 3, 6, 9 and 12 months.
Key secondary outcomes:
Response to treatment
Objective response (measured by RECIST criteria according to Complete Response, Partial Response, Stable Disease, Progression). Measurement time: at baseline, 3, 6, 9 and 12 months.
Related to Safety
Adverse Events-AE (Type of AE (AE description), Intensity of AE (Light, Moderate, Severe, Very Severe, Event related Death), Causality relationship (Very likely, Probable, Possible, Unlikely, Uncontrolled, Unclassifiable), Applied Treatment (None, Medication, Surgical Procedure, Transfusion, Other), Event Result (Recovered, Continued, Unknown, Death due to event)). Measurement time: at baseline, 3, 6, 9 and 12 months.