UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study on the safety of comprehensive therapy against hepatocarcinoma: combination of TAE and RFA , dendric cell
Acronym	A clinical study on the safety of comprehensive therapy against hepatocarcinoma: combination of TAE and RFA , dendric cell
Scientific Title	A clinical study on the safety of comprehensive therapy against hepatocarcinoma: combination of TAE and RFA , dendric cell
Scientific Title:Acronym	A clinical study on the safety of comprehensive therapy against hepatocarcinoma: combination of TAE and RFA , dendric cell
Region	Japan

Condition
Condition	Hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aims at safety evaluation of integrated cancer treatment with TAE, RFA and dendric cell against primary hepatocellular carcinoma above Stage II.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Safety Safety is assessed at the first blood collection for cell preparation and from TAE to two weeks after RFA.
Key secondary outcomes	Efficacy Recurrence-free survival time is evaluated by image diagnosis after RFA.

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	Vaccine Maneuver
Interventions/Control_1	Trans-arterial embolization (TAE) with more than 5.0 x 10^6 dendritic cells is performed. Radiofrequency ablation is performed from 3-6 weeks after TAE and DCs.
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	1) Patients must be diagnosed as primary hepatocellular carcinoma pathologically or from images. 2) Patients must be inoperable. 3) Patients must have Karnofsky Performance Status above 70. 4) Patients must have one or more tumor of maximum diameter larger than 2.5 cm. The number of tumor must not exceed 5. 6) Patient must be over 20 years old at registration. 7) Patients must weigh over 50 kg. 8) Liver damage or Child-pugh classificaion must be A or B according to latest clinical guideline for primary hepatocellular carcinoma. 9) Bone marrow and kidney function should be adequate at qualification confirmation. 10) Written consent should be obtained for participation to this study. 11) Patient must be capable of outpatient visits.
Key exclusion criteria	1) Patients must not have heart disorder, kidney disorder, respiratory disorder, hematopathy, clotting disorder, or other serious complication. 2) Patients must not be HIV positive. 3) Patients must not have carcinoma nor immunodeficiency in past history. 4) Patients must not have splenectomy nor splen radiation in past history. 5) Patients must not have allo organ transplantation in past history. 6) Patients must not subjected to continuous whole body administration of adrenal cortical steroid or antihistaminic. 7) Patients must have no surgery, chemotherapy nor radiation within 4 weeks before blood collection for treatment in this study. In addition, patients are also excluded if they have not recovered enough from those therapies above. 8) Female patients are excluded from the study when they are pregnant, possibly pregnant, or when they want to be pregnant or they are feeding. 9) Patients must be excluded when expected to be difficult to follow-up. 10) Patients must be excluded when principal investigator judge as inadequate.
Target sample size	3

Research contact person
Name of lead principal investigator	1st name Shuichiro Middle name Last name Shiina
Organization	Juntendo University Hospital
Division name	Department of Gastroenterology
Zip code	113-8431
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	sshiina@juntendo.ac.jp

Public contact
Name of contact person	1st name Shuichiro Middle name Last name Shiina
Organization	Juntendo University Hospital
Division name	Department of Gastroenterology
Zip code	113-8431
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	sshiina@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Juntendo University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Second Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Review Board of Juntendo University Faculty of Medicine
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo
Tel	03-3813-3176
Email	rinri@juntendo.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTc030190263
Org. issuing International ID_1	jRCT (Japan Registry Clinical Trials)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	順天堂大学医学部附属順天堂医院（東京都） 福井大学医学部附属病院（福井県）

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 01 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	Terminated
Date of protocol fixation	2018 Year 07 Month 31 Day
Date of IRB	2018 Year 11 Month 01 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2020 Year 01 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Transition to jRCT (Japan Registry Clinical Trials).

Management information
Registered date	2019 Year 03 Month 01 Day
Last modified on	2020 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041018