Table 3.

Clinical trials on pancreatic ductal adenocarcinoma using vaccines

National clinical trial number	Sample	Phase	Settings	Drug	Results
UMIN000004919	31	I/II	Metastatic ≥ Second line	KIF20A-66	KIF20A-66 vaccine: OS 4.7 m ± 0.8; Best supportive care: OS 2.7 m ± 1.1
UMIN000000905	6	I	Advanced (gastrointestinal and endocrine malignancies) ; Any line	SVN-2B; IFA; INFa	> 50% of the patients had positive clinical and immunological responses
NCT00569387	73	II	Adjuvant treatment	Algenpantucel-L	12-m OS: 86%
Kaufman et al, J Transl Med 2007; 5: 60	10	I	Advanced; Metastatic; Any line	MUC1; HLA-A2; ICAM-1; LFA-3; CM-CSF	antiCEA/MUC-1 positive: OS 15.1 m; antiCEA/MUC-1 negative: OS 3.9 m
Lepisto et al, Cancer Ther 2008; 6: 955–964	12	I/II	Adjuvant treatment	MUC1 peptide-loaded DC vaccine	Four of twelve patients are still alive without disease recurrence
NCT01410968	12	I	Advanced; Metastatic; Any line	w/Poly-ICLC peptide-pulsed DC-CIK	OS 7.7 m
Gjertsen et al, Int J Cancer 2001; 92: 441–50	48	I/II	Surgically resected; Advanced; Any line	K-Ras vaccine GM-CSF	Resected: OS 25.6 m (95%CI: 10-39); Unresectable: OS 10.2 m (95%CI: 3-28)
Abou-Alfa et al, Am J Clin Oncol 2011; 34: 321–5	24	I	Adjuvant (KRAS mutant)	Ras-peptide GM-CSF	OS 20.3 (95%CI: 11.6-45.3)
Bernhardt et al, Br J Cancer 2006; 95: 1474–1482	48	I/II	Advanced Treatment naive	GV1001; GM-CSF	Responders: OS 7.2 m (95%CI: 4.8-10.7); Non-responders: OS 2.9 m (95%CI: 1.7-6.30)
Shima et al, Cancer Sci 2019; 110: 2378-2385	83	II	Unresectable ≥ Second line	Survivin 2B peptide (SVN-2B); Interferon-β	SVN-2B + IFNβ: OS 312 d (95%CI: 43-460); IFNβ: OS 39 d (95%CI: 13-153)

CIK: cytokine-induced killer ; DC: dendritic cells; GM-CSF: granulocyte-macrophage colony-stimulating factor; IFN: interferon; m: months; OS: overall survival; PDAC: pancreatic ductal adenocarcinoma; PFS: progression-free survival.