Flow diagram of patient disposition.
pancreatic adenocarcinoma
DISEASE, PANCREATIC ADENOCARCINOMA
A total of 511 pancreatic adenocarcinoma patients were screened, of 148 patients were enrolled. Patients with high serum eotaxin levels (>81.02 pg/mL) were randomly assigned in a 2:1 ratio to receive either Gemcitabine/Capecitabine with GV1001 (GV1001 group) or Gemcitabine/Capecitabine (control group). Finally, 148 patients were assigned to the GV1001 group (Every eligible patient was checked for their serum eotaxin level at screening prior to randomisation: a total of 4 mL of blood was collected and shipped to the central laboratory (Seoul Clinical Laboratories, Seoul, Korea). The serum eotaxin level was quantified using the Bio-Plex Pro human cytokine singleplex (Eotaxin) assay kit with a Bio-Plex 200 System (Bio-Rad Laboratories, Inc, Hercules, CA, USA) in accordance with the manufacturer’s instructions.Patients with high serum eotaxin levels (>81.02 pg/mL) were randomly assigned in a 2:1 ratio to receive either GemCap with GV1001 (GV1001 group) or GemCap (control group). Patients with low serum eotaxin levels were assigned only to the control group to ensure that the control group included eotaxin-high and eotaxin-low patients in a 1:1 ratio. Consequently, the GV1001 group consisted of patients with high serum eotaxin levels, and the control group consisted of eotaxin-high and eotaxin-low patients in a 1:1 ratio. GemCap treatment included gemcitabine (1000 mg/mRandomisation was stratified based on the stage of disease (locally advanced vs. metastatic). The allocation sequence was generated by the CRO and the patients were randomly assigned to the treatments by trained authorised staff. All patients and investigators were aware of the treatment allocation.