UMIN-CTR Clinical Trial

Basic information
Public title	A Randomized PhaseI/ II study of HSP70mRNA transfected Dendritic Cells for the the Adjuvant immunotherapy of Hepatocellular carcinoma
Acronym	H7DCAH study
Scientific Title	A Randomized PhaseI/ II study of HSP70mRNA transfected Dendritic Cells for the the Adjuvant immunotherapy of Hepatocellular carcinoma
Scientific Title:Acronym	H7DCAH study
Region	Japan

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

Objectives
Narrative objectives1	Safety
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	1 year Desease-Free Survival rate
Key secondary outcomes	Safety Overall survival

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Vaccine Other
Interventions/Control_1	Surgey and HSP70mRNA transfected Dendritic Cells for the the Adjuvant immunotherapy
Interventions/Control_2	surgery alone
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. Diagnosed HCCs by dynamic CT or MRI and tumor markers 2. No therapy before 30 days for hepatectomy 3. R0 resection for Stage 2-4A (LIver cancer study group of Japan)
Key exclusion criteria	Without underlying diseases and allergy
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Masaaki Middle name Last name Oka
Organization	Yamaguchi University Graduate School of Medicine
Division name	Digestive Surgey and Surgical Oncology
Zip code	755-8505
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL	+81-836-22-2264
Email	hazama@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Shoichi Middle name Last name Hazama
Organization	Yamaguchi University Graduate School of Medicibe
Division name	Digestive Surgey and Surgical Oncology
Zip code	755-8505
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL	+81-836-22-2264
Homepage URL	http://ds.cc.yamaguchi-u.ac.jp/~surg2/
Email	hazama@yamaguchi-u.ac.jp

Sponsor
Institute	Digestive Surgey and Surgical Oncology,Yamaguchi University Graduate School of Medicibe
Institute
Department

Funding Source
Organization	A Grant-in-Aid for Scientific Research of the Ministry of Education, Science, Sports and Culture of Japan (project No. 23591988).
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Clinical Laboratory, Yamaguchi University Hospital.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yamaguchi University
Address	1-1-1 Minami-Kogushi
Tel	81836222264
Email	hazama@yamaguchi-u.ac.jp

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	山口大学大学院消化器・腫瘍外科学

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 11 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	2012 Year 06 Month 20 Day
Date of IRB	2012 Year 07 Month 13 Day
Anticipated trial start date	2012 Year 07 Month 13 Day
Last follow-up date	2019 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 05 Month 10 Day
Last modified on	2020 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009927