UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012702 |
|---|---|
| Receipt number | R000014798 |
| Scientific Title | Clinical study of dendritic cell vaccine combined with transarterial embolization for patients with hepatocellular carcinoma |
| Date of disclosure of the study information | 2013/12/26 |
| Last modified on | 2016/01/04 23:27:26 |
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Basic information
Public title
Clinical study of dendritic cell vaccine combined with transarterial embolization for patients with hepatocellular carcinoma
Acronym
Dendritic cell vaccine with transarterial embolization for HCC
Scientific Title
Clinical study of dendritic cell vaccine combined with transarterial embolization for patients with hepatocellular carcinoma
Scientific Title:Acronym
Dendritic cell vaccine with transarterial embolization for HCC
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of dendritic cell vaccine with transarterial embolization for hepatocellular carcinoma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of the treatment
Key secondary outcomes
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
| Vaccine |
Interventions/Control_1
Intraarterial infusion of dendritic cell vaccine
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
(1) Proven HCC patients
(2) Karnofsky Performance Status 70 %= or <
(3) Liver damage(Child-Pugh) A or B
(4) Preserved bone marrow function
(5) Preserved renal function
(6) Written informed consent
Key exclusion criteria
1) Severe concurrent disease
2) HIV antibody and/or HTLV-1 antibody positive
3) No other malignancy
4) No splenectomy
5) No Allograft transplantation
6) No immunosuppressive treatment
7) No treatment for HCC within 4 weeks
8) Pregnant and lactating females
9) Inappropriate for entry onto this study in the judgment of the investigator
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunari Nakamoto |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Second Department of Internal Medicine
Zip code
Address
23-3 Matsuoka-shimoaitsuki, Eiheiji-cho, Fukui 910-1193, Japan
TEL
0776-61-8351
ynakamot@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Nemoto |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Second Department of Internal Medicine
Zip code
Address
23-3 Matsuoka-shimoaitsuki, Eiheiji-cho, Fukui 910-1193, Japan
TEL
0776-61-8351
Homepage URL
nemotot@u-fukui.ac.jp
Sponsor or person
Institute
Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medical Sciences, University of Fukui
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seta Clinic
Name of secondary funder(s)
MEDINET Co., Ltd.
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 12 | 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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 24 | 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
| 2013 | Year | 12 | Month | 26 | Day |
Last modified on
| 2016 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014798
