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

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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 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


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

Value
https://center6.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