UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011184 |
|---|---|
| Receipt number | R000013094 |
| Scientific Title | Hepatic arterial infusion of autologous gamma/delta T cell for advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2013/07/12 |
| Last modified on | 2016/09/29 10:59:26 |
* 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
Hepatic arterial infusion of autologous gamma/delta T cell for advanced hepatocellular carcinoma
Acronym
Hepatic arterial infusion of autologous gamma/delta T cell for advanced hepatocellular carcinoma
Scientific Title
Hepatic arterial infusion of autologous gamma/delta T cell for advanced hepatocellular carcinoma
Scientific Title:Acronym
Hepatic arterial infusion of autologous gamma/delta T cell for advanced hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of transcatheter hepatic arterial infusion of autologous gamma/delta T cells and zoledronic acid.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Key secondary outcomes
In vivo dynamics (Gamma/delta T cells)
Pharmacokinetics (Zoledronic acid)
Efficacy
Immunological responses
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 | Maneuver |
Interventions/Control_1
Transcatheter hepatic arterial infusion
- Zoledronic acid (2mg/day); day-7, 0, 14, 28, 42, 56, 70
- Gamma/delta T cells; 0, 14, 28, 42, 56, 70
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
Advanced hepatocellular carcinoma patients who are refractory to the standard therapy including sorafenib and meet the following criteria:
- Pathological or imaging diagnosis as hepatocellular carcinoma;
- No influence by previous treatment;
- Life-expectancy is more than 3 months;
- Performance Status is 0-1;
- No serious abnormality in heart, lung, liver, renal, and bone marrow functions;
- Eligible for transcatheter hepatic arterial infusion
Key exclusion criteria
Patients who have:
- Pulmonary fibrosis or interstitial pneumonia, including their history or predisposition;
- Serious drug allergy;
- Serious cardiac disease;
- Active inflammatory bowel disease,
- Active autoimmune disease;
- Other cancers;
- Active infections;
- Pleural effusion or ascite that requires drainage procedure;
- Pregnant, to be pregnant, or nursing mothers;
- Positive for HIV or HTLV-1;
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
The University of Tokyo Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, Artificial Organ and Transplantation Surgery Division
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5215-0086
KOKUDO-2SU@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kakimi |
Organization
The University of Tokyo Hospital
Division name
Department of Immunotherapeutics
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5805-3163
Homepage URL
immunotherapy-admin@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kyoundo Hospital, Sasaki Foundation
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
東京大学医学部附属病院（東京都）、佐々木研究所附属杏雲堂病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 12 | 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 | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2016 | 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
| 2013 | Year | 07 | Month | 12 | Day |
Last modified on
| 2016 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013094
