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):
Overall survival (Time from randomization until death from any cause). Measurement time: weekly during the first 8 weeks) and, later, monthly for two years.
Time to radiological progression (Time since patient recruitment until objective tumor progression). Measurement time: 12 and 24 months.
Key secondary outcomes:
Tumor evolution (modified RECIST criteria -mRECIST- and, -RECIL- Response Evaluation Criteria in Cancer of the Liver): Measurement time: 12 and 24 months.
Adverse clinical events-AE (occurrence of AE (Yes, No) Description of AE (event name) Intensity of AE (mild, moderate, severe)). Measurement time: at baseline, weekly in during the first 8 immunizations, and thereafter with a monthly frequency throughout the study period.
Laboratory (numerical values of hematological and biochemical tests). Measurement time: at baseline and, at weeks 13, 25, 49 and 73.
Humoral immune response (determination of anti-VEGF antibody titers; percent inhibition - VEGF binding and its receptor). Measurement time: At weeks 13, 25, 49 and 73.
Cellular immune response (ELISPOT for interferon gamma: average number of spots). Measurement time: At week 49.
Quality of life (EORTC survey QLQ-C30). Measurement time: at baseline and, months 12 and 24.