UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003861 |
|---|---|
| Receipt number | R000004628 |
| Scientific Title | Efficacy of adoptive cellular therapy with naive rich T cell on recurrence after curative radiofrequency ablation for primary hepatocellular carcinoma (Phase 2 study) |
| Date of disclosure of the study information | 2010/07/05 |
| Last modified on | 2016/01/04 15:33:03 |
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Basic information
Public title
Efficacy of adoptive cellular therapy with naive rich T cell on recurrence after curative radiofrequency ablation for primary hepatocellular carcinoma (Phase 2 study)
Acronym
HCC prevention study by naive rich T cell therapy
Scientific Title
Efficacy of adoptive cellular therapy with naive rich T cell on recurrence after curative radiofrequency ablation for primary hepatocellular carcinoma (Phase 2 study)
Scientific Title:Acronym
HCC prevention study by naive rich T cell therapy
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the inhibitory effects of adoptive cellular therapy with naive rich T cell on the recurrence after curative RFA for HCC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Three-year recurrence-free survival
Key secondary outcomes
overall survival, disease-specific survival, immunological response, safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
adoptive cellular 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The following HCC patients who are curatively treated with RFA.
1. not less than 20, less than 80 years of age.
2. Performance status of the patients are 0-2.
3. Child-Pugh class A or B.
4. Bone marrow function and hepatic/renal functions are well maintained.
a White blood cell count more than 2000/mm3, less than 10000/mm3.
b. Platelet count more than 50000/mm3.
c. AST and ALT less than 150IU/L
d. T. Bil less than 3.0mg/dl.
e. Cr less than 1.5mg/dl
5. All patients gave written informed consent.
Key exclusion criteria
1. Patient who has uncontrollable severe infectional disease.
2. Patient who has allergic disease or autoimmune disease requiring treatment.
3. Patient who is associated with malignant hypertension, severe congestive heart disease, unsatble angina, myocardial infarction within 6 months prio to registration, severe pulmonary fibrosis and active interstitial pneumonia.
4. Patient who cannot undergo enhanced CT scan or MRI due to some reason such as allergy for contrast media or renal dysfunction.
5. Patient who has uncontrollable associated cancer.
6.Patient with severe drug allergy.
7.Patient with severe psychiatric disorder.
8.In pregnancy or lactation.
9. Patient with HIV or HTLV-1 infection.
10.Patient who is inappropriate.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kokura |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
Kajii-cho, Kamigyo-ku, Kyoto
TEL
075-251-5519
s-kokura@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Ishikawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
Kaji-cho 465, Kamigyo-ku, Kyoto
TEL
075-251-5519
Homepage URL
iskw-t@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Division of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Japanease Foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
京都府立医科大学附属病院（京都府）、医聖会百万遍クリニック（京都府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 05 | 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
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 02 | Day |
Last modified on
| 2016 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004628
