Study end points
death, Tumour, TTP, tumour, Cancer
ADVERSE EVENT, TUMOUR, PROLIFERATION, ADVERSE EVENTS, DISEASE, SECONDARY, TUMOUR, TTP, CANCER
For primary end points, OS was defined as the time from the date of the first randomisation to the date of death from any cause. For secondary end points, time to progression (TTP) was defined as the time from the date of the first randomisation to the date of tumour progression. Patients were followed up for survival until death, withdrawal, or study closure. The other secondary end points were objective tumour response rate (ORR), quality of life (QoL), changes in serum carbohydrate antigen 19-9 (CA 19-9) concentration over time, immunogenicity measured as T-cell proliferation, and safety.Tumour outcome was evaluated at baseline, after 8 weeks, and every 12 weeks by CT or MRI until the end of the trial. Objective tumour response was defined as the ratio of patients confirmed with complete or partial responses. Tumour control rate was defined as the ratio of the patients confirmed with complete or partial responses or stable disease. Serum CA 19-9 was measured at baseline, at weeks 5, 8, 14 and 22 and every 4 weeks thereafter. Safety was monitored for treatment-related adverse events (AEs) and for serious AEs before each cycle of chemotherapy. Treatment-related AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03).