UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000971 |
|---|---|
| Receipt number | R000001167 |
| Scientific Title | Clinical study of intratumoral dendritic cells(DC) injection after radiofrequency ablation(RFA) therapy for the treatment of hepatitis C virus-related hepatocellular carcinoma(HCC) patients |
| Date of disclosure of the study information | 2008/01/07 |
| Last modified on | 2011/02/08 14:14:42 |
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Basic information
Public title
Clinical study of intratumoral dendritic cells(DC) injection after radiofrequency ablation(RFA) therapy for the treatment of hepatitis C virus-related hepatocellular carcinoma(HCC) patients
Acronym
Intratumoral DC injection after RFA for the treatment of HCC
Scientific Title
Clinical study of intratumoral dendritic cells(DC) injection after radiofrequency ablation(RFA) therapy for the treatment of hepatitis C virus-related hepatocellular carcinoma(HCC) patients
Scientific Title:Acronym
Intratumoral DC injection after RFA for the treatment of HCC
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of intratumoral DC injection after RFA for the treatment of hepatitis C virus-related HCC patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Key secondary outcomes
Immunological responses, Clinical responses
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
Intratumoral dendritic cells injection
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
HCV-related HCC patients who are not completely controlled by hepatic resection, local treatment, embolization therapy, hepatic intra-arterial chemotherapy and so on, and who meet the followings :
- RFA is applicable;
- Performance status is 0-1;
- No serious abnormality in bone marrow, liver, and renal functions.
Key exclusion criteria
Patients who have:
- Interstitial pneumonia, pulmonary fibrosis, or drug-induced pneumonia , or predisposition to them;
- Continuous systemic administration of steroids;
- Active autoimmune diseases or predisposition to them;
- Other cancers;
- Uncontrolled infection
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fuminori Moriyasu/Kazuhiro Kakimi |
Organization
Tokyo Medical University/The University of Tokyo
Division name
Department of Gastroenterology and Hepatology/Department of Immunotherapeutics (Medinet)
Zip code
Address
6-7-1, Nishi-Shinjyuku, Shinjyuku-Ku, Tokyo, Japan/7-3-1, Hongo, Bunkyo-Ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
6-7-1, Nishi-Shinjyuku, Shinjyuku-Ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Tokyo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Graduate School of Medicine, The University of Tokyo
Seta Clinic Shin-Yokohama
Name of secondary funder(s)
Medinet Co.,Ltd
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Three patients with advanced hepatocellular carcinoma received intratumoral injections of dendritic cells after radiofrequency ablation therapy.
In this study, no serious adverse event was observed. The treatment was safe and feasible.
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
| 2007 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 07 | Day |
Last modified on
| 2011 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001167
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
