UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Hepatic arterial infusion of autologous gamma/delta T cell for advanced hepatocellular carcinoma
Title of the study (Brief title)	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	Norihiro Kokudo
Organization	The University of Tokyo Hospital
Division name	Hepato-Biliary-Pancreatic Surgery Division, Artificial Organ and Transplantation Surgery Division
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	Kazuhiro Kakimi
Organization	The University of Tokyo Hospital
Division name	Department of Immunotherapeutics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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