Unique ID issued by UMIN | UMIN000005549 |
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Receipt number | R000006581 |
Scientific Title | Cancer vaccine therapy using epitope peptide from CDH3 restricted to HLA-A*2402 with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer (Phase I study) |
Date of disclosure of the study information | 2011/05/03 |
Last modified on | 2011/05/03 12:20:46 |
Cancer vaccine therapy using epitope peptide from CDH3 restricted to HLA-A*2402 with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer (Phase I study)
Cancer vaccine therapy using epitope peptide from CDH3 restricted to HLA-A*2402 with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer (Phase I study)
Cancer vaccine therapy using epitope peptide from CDH3 restricted to HLA-A*2402 with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer (Phase I study)
Cancer vaccine therapy using epitope peptide from CDH3 restricted to HLA-A*2402 with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer (Phase I study)
Japan |
pancreatic cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
The aim of this study is to examine the safety of epitope peptide from CDH3 restricted to HLA-A*2402 with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer
Safety
Exploratory
Phase I
Safety
Immunological response, Antitumor efficacy, Time to progression, Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Vaccine |
vaccination using epitope peptide from CDH3 restricted to HLA-A*2402 with gemcitabine chemotherapy
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1)Patients who have unresectable advanced pancreatic cancer
2)The presence or absence of measurable or evaluable lesions by RECIST was not taken into account.
3)Performance status (ECOG) of the patients are 0-2.
4)more than 20, less than 80 years of age.
5)Patients who can expect the survival of three months or more.
6)Patients who have undergone operation, and recovered the influence by surgery. Or two weeks or more have passed since pre-medical treatment.
7)without dysfunction of multiple major organs
8)with HLA-A*2402
9)Patients who have not been treated with gemcitabine.
10)All patients gave written informed consent.
1)Pregnancy or lactation
2)Patients with the intention of pregnancy.
3)Patients have uncontrollable severe infectional diseases.
4)Patients who are treated with steroid or immunotherapy during clinical trial.
5)Patients have uncontrollable multiple cancer.
6)Patients who have non-recovered injury.
7)Patients who have ileus and interstitial lung disiease.
8)Patients whom doctors define as inappropriate.
9
1st name | |
Middle name | |
Last name | Yasuhisa Shinomura |
Sapporo Medical University
1st Department of Internal Medicene
Nishi 16, Minami 1, Chuoku, Sapporo
1st name | |
Middle name | |
Last name | Masayo Hosokawa |
Sapporo Medical University
1st Department of Internal Medicene
011-611-2111
Sapporo Medical University
Sapporo Medical University, 1st Department of Internal Medicine
Self funding
NO
2011 | Year | 05 | Month | 03 | Day |
Unpublished
No longer recruiting
2010 | Year | 02 | Month | 22 | Day |
2010 | Year | 04 | Month | 01 | Day |
2011 | Year | 05 | Month | 03 | Day |
2011 | Year | 05 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006581
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