UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Adoptive immunotherapy using donor liver NK cells for preventing recurrence of hepatocellular carcinoma after liver transplantation
Title of the study (Brief title)	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	Hideki Ohdan
Organization	Hiroshima University
Division name	Gastroenterology and transplant surgery
Address	1-2-3 Kasumi, Minamiku, Hiroshima
TEL	082-257-5222
Email	hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person	Masahiro Ohira
Organization	Hiroshima University
Division name	Gastroenterology and transplant surgery
Address	1-2-3 Kasumi, Minamiku, Hiroshima
TEL	082-257-5222
Homepage URL
Email	mohira@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 03 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014219