UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pjase I study of peptide vacicination using eitope petide derived from novel oncoantigen for patients with metastatic or recuurent cholangiocarcinoma
Title of the study (Brief title)	Phase I study of peptide vaccination for patients with cholangiocarcinoma
Region	Japan

Condition
Condition	cholangiocarcinoma
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the safty of cancer specific antigen -derived peptide vaccines and gemcitabine for cholangiocarcinoma. This is clinical study collaborated with Professor Yusuke Nakamura, Institute of Medical Science, the University of Tokyo.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Evaluation of safety of peptide vaccine and gemcitabine
Key secondary outcomes	Immunological Response, Respoense rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Vaccine
Interventions/Control_1	peptide vaccination
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Despite former therapy, Recurrence or being excision impossible cholangiocarcinoma case which desires vaccine therapy. 2) Age between 20 and 85 3) HLA-A*2402 4)Performance status (ECOG) 0 or 1 5)obtains lesion which can be evaluated by RECIST 6)more than 4 weeks after prior therapy 7)without dysfunction of multiple major organs 8) more than 3 months of prognosis 9) obtains written informed consent
Key exclusion criteria	1.severe ischemic heart disease and arrythmia 2. pregnant woman 4. severe active infection disease 5. pateients required administration of steroids 6.multiple cancer patients
Target sample size	9

Research contact person
Name of lead principal investigator	Nobuya Yamada
Organization	Osaka City University Graduate School
Division name	Surgical Oncology
Address	1-4-3, Asahimachi, Abenoku, Osaka
TEL	06-6645-3838
Email	nyamada@med.osaka-cu.ac.jp

Public contact
Name of contact person	Hiroaki Tanaka
Organization	Osaka City Osaka CIty University Graduate School
Division name	Surgical Oncology
Address	1-4-3, Asahimachi, Abenoku, Osaka
TEL	06-6645-3838
Homepage URL
Email	hiroakitan@med.osaka-cu.ac.jp

Sponsor
Institute	Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪市立大学付属病院

Other administrative information
Date of disclosure of the study information	2010 Year 12 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 12 Month 01 Day
Anticipated trial start date	2010 Year 01 Month 01 Day
Last follow-up date	2012 Year 11 Month 30 Day
Date of closure to data entry	2012 Year 11 Month 30 Day
Date trial data considered complete	2012 Year 11 Month 30 Day
Date analysis concluded	2012 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 12 Month 02 Day
Last modified on	2016 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005551