The early studies were applied in a phase I/II clinical trial in patients with HLA-A * 0201-expressing stage II-IVA hepatocellular carcinoma. Vaccine therapy, comprising AFP and sargramostim (GM-CSF) plasmids DNA, followed by AFP adenoviral vector boost determined the dose-limiting toxicity and maximum tolerated dose of adjuvant vaccination (ClinicalTrials.gov Identifier: NCT00093548).