UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036065 |
|---|---|
| Receipt number | R000041018 |
| Scientific Title | A clinical study on the safety of comprehensive therapy against hepatocarcinoma: combination of TAE and RFA , dendric cell |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2020/03/26 18:00:51 |
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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
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
sshiina@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041018
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