UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022082 |
|---|---|
| Receipt number | 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 | 2022/11/01 11:28:45 |
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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
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
geka2dm@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
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
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
Terminated
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
| 2022 | 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
| 2022 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025460
