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):
-Immunocompetence of patients (Frequency and phenotype of B lymphocytes, T and NK cells). Measurement time: At baseline, at the end of the induction stage (day 84) and, every three months until the 15 doses are met.
-Immune response (Title and functionality of antibodies induced by the vaccine). Measurement time: At baseline, at the end of the induction stage (day 84) and, every three months until the 15 doses are met.
-Inhibition of tumor angiogenesis (Concentration of biomarkers related to angiogenesis and tumor inflammation: IL 8, VEGF, FGF, EGF, IL 6) Measurement time: At baseline, at the end of the induction stage ( day 84) and then every three months until the 15 doses
-Overall Survival: (Time from recruitment until to death, from any cause). Measurement time: 24 months
Key secondary outcomes:
Laboratory tests (numerical values of the Hemogram with differential, GPT, GOT, GGT, Alkaline Phosphatase, LDH, Creatinine, Glycemia). Measurement time: At baseline and, very three months until 24 months.