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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011184
Receipt No. 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

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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
Email 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
Email immunotherapy-admin@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013094

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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