UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010691 |
|---|---|
| Receipt number | R000009927 |
| Scientific Title | A Randomized PhaseI/ II study of HSP70mRNA transfected Dendritic Cells for the the Adjuvant immunotherapy of Hepatocellular carcinoma |
| Date of disclosure of the study information | 2013/05/11 |
| Last modified on | 2020/05/18 11:21:18 |
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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
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/
hazama@yamaguchi-u.ac.jp
Sponsor or person
Institute
Digestive Surgey and Surgical Oncology,Yamaguchi University Graduate School of Medicibe
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009927
