UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001701 |
|---|---|
| Receipt number | R000002048 |
| Scientific Title | Combined therapy of radiofrequency ablation with intratumoral dendritic cell infusion for hepatocellular carcinoma: clinical safety |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2024/08/28 15:57:27 |
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Basic information
Public title
Combined therapy of radiofrequency ablation with intratumoral dendritic cell infusion for hepatocellular carcinoma: clinical safety
Acronym
Combined therapy of radiofrequency ablation with intratumoral dendritic cell infusion for hepatocellular carcinoma: clinical safety
Scientific Title
Combined therapy of radiofrequency ablation with intratumoral dendritic cell infusion for hepatocellular carcinoma: clinical safety
Scientific Title:Acronym
Combined therapy of radiofrequency ablation with intratumoral dendritic cell infusion for hepatocellular carcinoma: clinical safety
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
Immature dendritic cell treatment
Interventions/Control_2
OK-432 stimulated dendritic cell treatment
Interventions/Control_3
No cell treatment control
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Advanced hepatocellular carcinoma
Key exclusion criteria
Immunodeficiency
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Kaneko |
Organization
Kanazawa University
Division name
Graduate school of medicine
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2235
s-kaneko@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yamashita |
Organization
Kanazawa University
Division name
University hospital
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL
0762652235
Homepage URL
ytatsuya@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University Hospital
Address
13-1 Takara-machi, Kanazawa, Ishikawa, Japan
Tel
076-265-2000
ytatsuya@m-kanazawa.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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | 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
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | 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
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002048
