Phase II clinical trial of combination of personalized peptide vaccination, Cyclophosphamide and Imiquimod for advanced Pancreatic cancer patients who failed standard therapy.

Phase II clinical trial of combination of personalized peptide vaccination, Cyclophosphamide and Imiquimod for advanced Pancreatic cancer patients who failed standard therapy. - Phase II study of peptide vaccination for advanced Pancreatic cancer patients.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011593

Enrollment

Registered

2013-08-28

Start date

2013-08-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

On administration day of the peptide vaccine,applicate Imiquimod(liniment cream) to the injection area, and wash away after 8 hours. Select vaccine peptides(up to 4)from 31 candidate peptides, to w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1)Parients must be diagnosed as Pancreatic cancer of the standard cancer of the standard therapy failed. 2)Patients must be at a score level 0 or 1 of ECOG performance status. 3)Patients must have igGs reactive to at least two of candidate peptides belongs to an apropriate group(s) for patient's HLA types. 4)Ptients must be expected to survive more than 3 months. 5)Patients must satisfy the followings: WBC is more than 2500/mm3 Lymphocyte is more than 900/mm3 Hb is more than 8.0g/dl Platelet is more than 50000/mm3 Serum Creatinine is less than 2.0mg/dl Total Bilirubin is less than 2.5mg/dl 6)Patients must be more 18 year-old. 7)Written informed consent must be obtained from patients. 8)Patients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.

Exclusion criteria

Exclusion criteria: The following patients must be excluded: 1)Patients with severe symptoms(active and severe infectious disease, circulatory disease, respiratory dusease, kidney disease, immunodeficuency, disease of coagulation. 2)Patients with the past history pf severe allergic reactions. 3)(Females) Patients who are during pregnancy, lactation expectant, and desiring future fertility. (Males) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination. 4)Patients who are judged inappropriate for the clinical trial by doctors.

Design outcomes

Primary

Measure	Time frame
Comparison between two groups of immune-enhancing effects.	—

Secondary

Measure	Time frame
1.Comparison between two groups of advere, safety of peptide vaccination 2.Comparison between two groups of long-term prognosis.	—

Countries

Japan

Contacts

Public ContactShigeru Yutani

Kurume University Cancer Vaccine Center

yutani@med.kurume-u.ac.jp0942-27-5210

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026