Phase II clinical trial of personalized peptide vaccination for standard therapy failed or unoperable Pancreatic cancer patients

Phase II clinical trial of personalized peptide vaccination for standard therapy failed or unoperable Pancreatic cancer patients - Peptide vaccination for Pancreatic cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001881

Enrollment

100

Registered

2009-04-14

Start date

2009-04-01

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

(1st treatment: total 6 times, every weeks) Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides that showed the highe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients must be diagnosed as standard therapy failed or unoperable Pancreatic cancer . The patients must be suffering from standerd therapy as Chemotherapy and Operation 2) Patients must be positive for HLA-A2,HLA-A24, HLA-A26, or HLA-A3 super type. 3) Patients must have IgG reactive to at least two of candidate peptides. 4) Patients must be at a score level 0~1 of performance status (PS) (ECOG). 5) Patients must be expected to survive more than 3 months. 6) Patients must satisfy the followings: WBC >= 2,500/mm3 Lymphocyte >= 900/mm3 Hb >= 8.0g/dl Platelet >= 50,000/mm3 Serum Creatinine <= 2.0mg/dl Total Bilirubin <= 2.5mg/dl 7) Patients must be more 18 year-old. 8) Written informed consent must be obtained from patients.

Exclusion criteria

Exclusion criteria: The following patients must be excluded: 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2)severe allergic reactions. 3) 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
Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.	—

Secondary

Measure	Time frame
1.Evaluation of long-term prognosis (progression free survival and total survival). 2.Adverse effects of peptide vaccination with estramustine / safety of the protocol is evaluated based on the NCI-CTC.	—

Countries

Japan

Contacts

Public ContactAkira Yamada

Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division

akiymd@med.kurume-u.ac.jp0942-31-7744

Outcome results

None listed

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