UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study to investigate recurrence efficacy on a combined use of radiofrequency ablation therapy and auto-gamma/delta T cell therapy for hepatitis C virus-related hepatocellular carcinoma patients.
Title of the study (Brief title)	Clinical study to investigate recurrence efficacy on a combined use of radiofrequency ablation therapy and auto-gamma/delta T cell therapy for hepatitis C virus-related hepatocellular carcinoma patients.
Region	Japan

Condition
Condition	Hepatitis C virus-related hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy on combination therapy of radiofrequency ablation therapy and auto-gamma/delta T cell therapy for hepatitis C virus-related hepatocellular carcinoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Recurrence-free survival rate
Key secondary outcomes	Recurrence-free survival Overall survival Disease-specific survival Immunological responses Safety

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	Maneuver
Interventions/Control_1	Auto-gamma/delta T cell therapy repeats 6 times every 2 weeks. Two days after first auto-gamma/delta T cell therapy, patients receive radiofrequency ablation therapy.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Hepatitis C virus-related hepatocellular carcinoma patients who meet the following: - 3 or fewer lesions, and each maximum diameter 3cm or less; - Child-Pugh score 5-7; - Performance status 0-1; - No serious abnormality in heart, lung, bone marrow, liver, and renal functions.
Key exclusion criteria	Patients who have: - Active enteritis; - Active autoimmune diseases; - Active infections; - Other cancers; - Other serious complications; - Continuous systemic administration of steroids.
Target sample size	40

Research contact person
Name of lead principal investigator	Fuminori Moriyasu
Organization	Tokyo Medical University
Division name	Fourth Department of Internal Medicine
Address	6-7-1, Nishishinjyuku, Shinjyuku-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
Organization	Tokyo Medical University
Division name	Fourth Department of Internal Medicine
Address	6-7-1, Nishishinjyuku, Shinjyuku-ku, Tokyo, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Tokyo Medical University
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	Seta Clinic Group
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	東京医科大学病院（東京都）、瀬田クリニック東京（東京都）、瀬田クリニック新横浜（神奈川県）

Other administrative information
Date of disclosure of the study information	2010 Year 11 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 29 Day
Anticipated trial start date	2010 Year 11 Month 01 Day
Last follow-up date	2015 Year 11 Month 01 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	2010 Year 11 Month 18 Day
Last modified on	2018 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005475