UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012162 |
|---|---|
| Receipt number | R000014219 |
| Scientific Title | Adoptive immunotherapy using donor liver NK cells for preventing recurrence of hepatocellular carcinoma after liver transplantation |
| Date of disclosure of the study information | 2013/10/29 |
| Last modified on | 2018/06/12 21:30:05 |
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Basic information
Public title
Adoptive immunotherapy using donor liver NK cells for preventing recurrence of hepatocellular carcinoma after liver transplantation
Acronym
Liver NK cell immunotherapy for liver transplant patients with HCC
Scientific Title
Adoptive immunotherapy using donor liver NK cells for preventing recurrence of hepatocellular carcinoma after liver transplantation
Scientific Title:Acronym
Liver NK cell immunotherapy for liver transplant patients with HCC
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reduce the recurrence of HCC after liver transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Recurrent free survival
Key secondary outcomes
Overall survival
Rejection rate
Infection rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Adoptive transfer of donor liver NK cells
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult liver transplant patients with HCC
Key exclusion criteria
No HCC patients
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Ohdan |
Organization
Hiroshima University
Division name
Gastroenterology and transplant surgery
Zip code
Address
1-2-3 Kasumi, Minamiku, Hiroshima
TEL
082-257-5222
hohdan@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Ohira |
Organization
Hiroshima University
Division name
Gastroenterology and transplant surgery
Zip code
Address
1-2-3 Kasumi, Minamiku, Hiroshima
TEL
082-257-5222
Homepage URL
mohira@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima 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
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
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 29 | 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
| 2005 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2006 | 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
| 2013 | Year | 10 | Month | 29 | Day |
Last modified on
| 2018 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014219
