UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	WT1 peptide-based cancer vaccine combined with gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a randomised, multicenter, phase 2 clinical study
Title of the study (Brief title)	Advanced pancreatic cancer GEM+WT1 vaccine RCT P2
Region	Japan

Condition
Condition	Pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Investigate the efficacy and safety of the combination therapy with gemcitabine and WT1 peptide-based cancer vaccine in the patients with advanced pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	1-year overall survival rate
Key secondary outcomes	Overall Survival(OS), 6-month OS rate, 1.5-year OS rate, Progression Free Survival, Disease control rate, Clinical benefit response, QOL, toxic effects, immunological monitoring, and non-immunological monitorings

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Combination therapy with GEM+WT1 vaccine 1) Gemcitabine: 1000mg/m2, day1, 8, 15, q28 intravenous injection, 30min. 2) WT1 peptide-based cancer vaccine: 3mg of WT1 peptide/body, day1, day15, q28 intradermal injection 2)-1 WT1 peptide mp235: HLA-A*2402 restricted WT1peptide or np126: HLA-A*0201 restricted WT1peptide 2)-2 Adjuvant Montanide ISA51
Interventions/Control_2	Gemcitabine alone 1) Gemcitabine: 1000mg/m2, day1, 8, 15, q28 intravenous injection, 30min.
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Diagnosed as pancreatic cancer 2) unresectable (UICC-stage III or IV) or recurrent pancreatic cnacer 3) Histologically or Cytologically proven pancreatic ductal adenocarcinoma 4) Karnofsky Performance Status 80-100% 5) Aged 20 to 79 years old 6) HLA-A*2402, A*0201 7) Without CNS metastases 8) Without moderate or more ascites / pleuraleffusion 9) No previous treatment against unresectable or recurrent advanced pancreatic cancer 10) No previous operation, chemotheraoy, or radiotherapy against any other malignancies, and no recurrence at least within 5 years 11) Able to eat by mouth 12) Adequate organ function 13) Written informed consent
Key exclusion criteria	1) Simultaneous or metachronous (within 5 years) double cancers, with exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women fo childearing potential, and men who want to get partner pregnat 3) Psychosis 4) Patients requiring systemic immunosuppresive agents, or moderate or higher dose of steroid with exception of usage for cancer pain 5) Pulmonary fibrosis or interstitial pneumonitis 6) Active bacterial or fungal infection 7) Severe complications 8) MDS, MDS/MPD, MPD 9) Severe drug allergy 10) Inadequate physical condition, as diagnosed by the primary physician
Target sample size	150

Research contact person
Name of lead principal investigator	Haruo Sugiyama
Organization	Osaka university Graduate school of Medicine
Division name	Functional Diagnostic Science
Address	1-7, Yamada-oka, Suita City, Osaka, Japan
TEL	06-6879-2593
Email	sugiyama@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person	Sumiyuki Nishida
Organization	Osaka university Graduate school of Medicine
Division name	Cancer Immunotherapy
Address	2-2, Yamada-oka, Suita City, Osaka, Japan
TEL	06-6879-3676
Homepage URL	http://sahswww.med.osaka-u.ac.jp/~hmtonc/vaccine/
Email	sumiyuki-n@imed3.med.osaka-u.ac.jp

Sponsor
Institute	Department of Cancer Immunotherapy, Osaka university Graduate school of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Dept. Surgery, Osaka Univ. graduate school of Med. Jikei University Tohoku Univ. graduate school of Med. Kansai Medical University Kyoto Prefectural Univ. Medicine Toho University Omori Medical center Kanagawa Cancer Center Sendai Open Hospital Teikyo University Hospital
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	大阪大学医学部附属病院（大阪府）、東京慈恵会医科大学附属柏病院（千葉県）、東北大学病院（宮城県）、関西医科大学附属枚方病院（大阪府）、京都府立医科大学附属病院（京都府）、東邦大学医療センター大森病院（東京都）、神奈川県立がんセンター（神奈川県）、仙台オープン病院（宮城県）、帝京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 03 Month 15 Day
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 03 Month 14 Day
Last modified on	2016 Year 09 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006238