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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003861
Receipt No. 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

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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
Email 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
Email iskw-t@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine, Division of Gastroenterology and Hepatology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004628

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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