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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022082
Receipt No. R000025460
Scientific Title A phase I study of combination immunotherapy with five peptides cocktail, CpG, and immune modulators for patients with advanced or metastatic colorectal cancer
Date of disclosure of the study information 2016/04/26
Last modified on 2019/10/29

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Basic information
Public title A phase I study of combination immunotherapy with five peptides cocktail, CpG, and immune modulators for patients with advanced or metastatic colorectal cancer
Acronym A phase I study of combination immunotherapy against mCRC
Scientific Title A phase I study of combination immunotherapy with five peptides cocktail, CpG, and immune modulators for patients with advanced or metastatic colorectal cancer
Scientific Title:Acronym A phase I study of combination immunotherapy against mCRC
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to evaluate the safety and clinical efficacy of combination immunotherapy for advanced colorectal cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes safety
Key secondary outcomes 1)specific CTL response
2)overall survival
3)progression-free survival
4)Response rate
5)disease control 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
Medicine
Interventions/Control_1 combination immunotherapy
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

Not applicable
Gender Male and Female
Key inclusion criteria Colorectal cancer refractory to standard therapy
Key exclusion criteria Uncontroled general complication.
etc
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Nagano
Organization Graduate School of Medicine
Division name Department of Gastroenterological, Breast and Endocrine Surgery
Zip code 755-8505
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2264
Email geka2dm@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Shoichi
Middle name
Last name Hazama
Organization YAMAGUCHI UNIVERSITY SCHOOL OF MEDICINE
Division name Department of Translational Research and Developmental Therapeutics against Cancer
Zip code 755-8505
Address 1-1-1 Minamikogushi , Ube, 755-8505, Japan
TEL +81-836-22-2324
Homepage URL http://www.yamadai-gesurgery.jp/archives/177
Email geka2dm@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

Funding Source
Organization Yamaguchi University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Yamaguchi University
Address 1-1-1 Minamikogushi , Ube, 755-8505, Japan
Tel 0836-22-2428
Email clin_res@yamaguchi-u.ac.jp

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

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 03 Month 02 Day
Date of IRB
2016 Year 03 Month 28 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 26 Day
Last modified on
2019 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025460

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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