Unique ID issued by UMIN | UMIN000004332 |
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Receipt number | R000005189 |
Scientific Title | Phase I/II study of postoperative adjuvant therapy with Gemcitabine plus peptide vaccine for pancreatic cancer. |
Date of disclosure of the study information | 2010/10/06 |
Last modified on | 2012/10/31 15:51:55 |
Phase I/II study of postoperative adjuvant therapy with Gemcitabine plus peptide vaccine for pancreatic cancer.
Phase I/II study of postoperative adjuvant therapy with Gemcitabine plus peptide vaccine for pancreatic cancer.
Phase I/II study of postoperative adjuvant therapy with Gemcitabine plus peptide vaccine for pancreatic cancer.
Phase I/II study of postoperative adjuvant therapy with Gemcitabine plus peptide vaccine for pancreatic cancer.
Japan |
Pancreatic cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
The aim of this study is to assess the safety and clinical efficacy of Gemicitabine plus peptide vaccine for pancreatic cancer in an adjuvant setting.
Safety,Efficacy
Phase I,II
Assessment of safety
Postoperative progression free survival
Postoperative overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Active
1
Prevention
Medicine | Vaccine |
Patients will be treated with Gemcitabine within 10 weeks after curative operation and vaccinated biweekly for 12 times. On each vaccination day, VEGFR1 and VEGFR2 peptide (1mg) are mixed with Montanide ISA-51 will be administered by subcutaneous injection.
20 | years-old | <= |
80 | years-old | > |
Male and Female
1.HLA-A2402 positive pancreatic cancer patients who received the curative operation
2.Age between 20 to 80
3.No severe organ function impairment
4.Written informed consent of the patient
5.Performance Status 0-2
1.Pregnancy or lactation
2.Decision of unsuitableness by principal investigatior
3.Patient with severe underlying disease
4.Patient with severe allergy disease
20
1st name | |
Middle name | |
Last name | Masakazu Yamamoto |
Tokyo Women's Medical University
Department of Gastroenterological Surgery
8-1 Kawada-cho, Shinjyuku-ku, Tokyo
1st name | |
Middle name | |
Last name | Takashi Hatori |
Tokyo Women's Medical University
Department of Gastroenterological Surgery
8-1 Kawada-cho, Shinjuku-ku. Tokyo
Tokyo Women's Medical University
Department of Gastroenterological Surgery, Tokyo Women's Medical University
Self funding
Human Genome Center, Institute of Medical Science, The University of Tokyo
NO
東京女子医科大学病院(東京都)
2010 | Year | 10 | Month | 06 | Day |
Unpublished
Completed
2008 | Year | 01 | Month | 10 | Day |
2008 | Year | 01 | Month | 01 | Day |
2010 | Year | 10 | Month | 06 | Day |
2012 | Year | 10 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005189
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