UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005667 |
|---|---|
| Receipt number | R000006703 |
| Scientific Title | Phase I/II study of adjuvant therapy after liver transplantation in the recipients with advanced hepoatocellular carcinoma |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2012/05/30 09:08:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase I/II study of adjuvant therapy after liver transplantation in the recipients with advanced hepoatocellular carcinoma
Acronym
Phase I/II study of adjuvant therapy after LTx in the recipients with advanced HCC
Scientific Title
Phase I/II study of adjuvant therapy after liver transplantation in the recipients with advanced hepoatocellular carcinoma
Scientific Title:Acronym
Phase I/II study of adjuvant therapy after LTx in the recipients with advanced HCC
Region
| Japan |
Condition
Condition
Liver transplant recipients with advanced hepatocellular carcinoma beyond Milan criteria
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Establishment of effective adjuvant therapy for the liver transplant recipients with advanced hepatocellular carcinoma beyond Milan criteria
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety, recurrence rate and site of HCC
Key secondary outcomes
graft survival, patient survival, incidence of acute cellular rejection and chronic rejection
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-1, Interferon
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
Liver transplant recipints with HCC over Milan criteria
Key exclusion criteria
renal dysfunction, ABO incompatible transplant, HIV positive, and others
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nagano |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Surgery
Zip code
Address
2-2 Yamadaoka, Suita
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine, Department of Surgery
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | 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
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
Open public recruiting
Date of protocol fixation
| 2005 | Year | 11 | Month | 08 | 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
| 2011 | Year | 05 | Month | 30 | Day |
Last modified on
| 2012 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006703
