The length of treatment ranged from 4- 6 cycles (i.e. up to 25 weeks) at a dose of 1000 mg/m 2 (Neoptolemos et al., 2010; Van Laethem et al., 2010). The start of the gemcitabine adjuvant treatment was up to 8 weeks following surgery. CT TG01 -01 Version v 10.0 27 June 2018 Confidential 48 / 87 Therefore, it seems appropriate to use gemcitabine as the primary chemotherapy for adjuvant treatment and provides a reasonable basis on which to compare disease -free and overa ll survival. However, considering that gemcitabine treatment may result in increased ALT/AST, patients may , in these instances , stop gemcitabine and take 5- FU/Leucovorin and continue GM-CSF/TG01 as planned per protocol or start with 5 - FU/Leucovorin if the enzymes are high at the outset . 3.3 Selection of trial population 6-32 patients with histologically or cytologically confirmed diagnosis of resected adenocarcinoma of the pancreas will be enrolled and treated with GM -CSF/TG01 with the intention of combining with gemcitabine as adjuvant chemotherapy. 3.3.1 Inclusion criteria For inclusion in the trial, patients must fulfil the following protocol entry criteria: 1. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas 2. Stage I or II disease (clinical stage T1 -3, N0-1, M0 by AJCC staging criteria).