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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020440
Receipt No. R000023614
Scientific Title A combination immunotherapy for the patients with advanced or metastatic solid cancer
Date of disclosure of the study information 2016/02/01
Last modified on 2021/01/12

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Basic information
Public title A combination immunotherapy for the patients with advanced or metastatic solid cancer
Acronym A combination immunotherapy for the patients with advanced or metastatic solid cancer
Scientific Title A combination immunotherapy for the patients with advanced or metastatic solid cancer
Scientific Title:Acronym A combination immunotherapy for the patients with advanced or metastatic solid cancer
Region
Japan

Condition
Condition solid cancer
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Breast surgery
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 immunotherapy for advanced solid cancer
Basic objectives2 Safety,Efficacy
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 solid cancer
Key exclusion criteria Uncontroled general complication.
etc
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Nagano
Organization Yamaguchi university 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 Nobuaki
Middle name
Last name Suzuki
Organization Yamaguchi university 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
Homepage URL
Email geka2dm@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi university Graduate School of Medicine
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Center For Clinical Research, Yamaguchi University Hospital
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel 0836-22-2428
Email me223@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 02 Month 01 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 17
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 Completed
Date of protocol fixation
2016 Year 01 Month 05 Day
Date of IRB
2019 Year 11 Month 27 Day
Anticipated trial start date
2016 Year 01 Month 05 Day
Last follow-up date
2020 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 01 Month 05 Day
Last modified on
2021 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023614

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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