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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029991
Receipt No. R000034249
Scientific Title A phase I study of combination adjuvant immunotherapy for patients with resectable hepatocellular carcinoma
Date of disclosure of the study information 2017/11/20
Last modified on 2018/03/30

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Basic information
Public title A phase I study of combination adjuvant immunotherapy for patients with resectable hepatocellular carcinoma
Acronym A phase I study of combination adjuvant immunotherapy for patients with resectable hepatocellular carcinoma
Scientific Title A phase I study of combination adjuvant immunotherapy for patients with resectable hepatocellular carcinoma
Scientific Title:Acronym A phase I study of combination adjuvant immunotherapy for patients with resectable hepatocellular carcinoma
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Surgery in general
Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to evaluate the clinical efficacy and safety of combination adjuvant immunotherapy for patients with resectable hepatocellular carcinoma
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 in PBMC
2)specific CTL response in the tumor
3)relapse-free survival
4)overall survival

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
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 resectable HCC
Key exclusion criteria Uncontroled general complication.
etc
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Nagano
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
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
Middle name
Last name Shoichi Hazama
Organization Yamaguchi University School of Medicine
Division name Department of Translational Research and Developmental Therapeutics against Cancer
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-3186
Homepage URL http://www.yamadai-gesurgery.jp/
Email hazama@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization CYTLIMIC Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 11 Month 20 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
2017 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 15 Day
Last modified on
2018 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034249

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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