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The novel therapeutic cancer peptide vaccine therapy for patients with locally advanced or metastatic pacreatic cancer combined with Gemcitabine as the first line therapy.-Phase I/II study-

The novel therapeutic cancer peptide vaccine therapy for patients with locally advanced or metastatic pacreatic cancer combined with Gemcitabine as the first line therapy.-Phase I/II study- - 1408PC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014481
Enrollment
40
Registered
2014-08-01
Start date
2014-08-01
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

novel peptide cocktail vaccine 1mL will be administered by subcutaneous injection on days, 1,8,15 and 22 of each 28-day treatment cycles.

Sponsors

Second Department of Surgery, Wakayama Medical University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Locally advanced or metastatic pancreatic ductal carcinoma histologically confirmed as adenocarcinoma or squamous cell carcinoma. 2)no prior chemotherapy and radiotherapy 3)KPS score>=80 4)HLA-A*24 or HLA-A*02 must be positive 5)Life Expectancy must be >=3 months 6)Adequate organ functions 7)The written consent form

Exclusion criteria

Exclusion criteria: 1)History of other active malignancy 2)Pancreatic cancer infiltrated into digestive tract with serious concern of bleeding 3)Interstitial pneumonia or pulmonary fibrosis 4)Brain metastasis or symptoms of it 5)Pleural effusion, ascites, and pericardial fluid requiring drainage 6)Active infections 7)Severe nervous disorder or mental disorder 8)Severe organ disorder, equivalent to CTCAE grade3 or greater 9)History of ischemic heart disease, cerebral infarction, or thromboembolism within 12 months 10)Evidence of bleeding diathesis or severe coagulopthy, or patients with those histories 11)Need continuous medication of anticoagulant drug except aspirin 12)Pregnant females or nursing mothers who can not stop lactation after the recruitment

Design outcomes

Primary

MeasureTime frame
overall survival

Countries

Japan

Contacts

Public ContactMotoki Miyazawa

Wakayama Medical University, School of Medicine Second Department of Surgery

mo-0702@wakayama-med.ac.jp073-441-0613

Outcome results

None listed

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