5. TRIAL MEASUREMENTS AND ENDPOINTS 5.1 Primary endpoint Safety • Adverse events • Laboratory assessments Immune response by week 11 or 12 (main group) or 13 (concomitant group) or 8 (modified vaccination group) , at end of the treatment period with chemotherapy and at end of study assessed by • DTH responses • Proliferative T- cell responses 5.2 Secondary endpoints Efficacy at 2 years • Disease- free survival • Overall survival 5.3 Exploratory endpoints • Relationship between KRAS status in resected primary tumour and recurrence survival outcomes (including disease recurrence and overall survival) • CA19 -9 level s CT TG01 -01 Version v 10.0 27 June 2018 Confidential 60 / 87 5.4 Screening assessments 5.4.1 Informed consent The Investigator must inform the patient verbally about the content of the trial and its risks and benefits, as outlined in the information for patients within the informed consent document. The patient should then be given sufficient time to read the information for patients and consider participation.