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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015463
Receipt No. R000017976
Scientific Title Phase II trial of Transarterial Chemoembolization using Drug-eluting bead for advanced HCC refractory to Lipiodol-TACE
Date of disclosure of the study information 2014/10/17
Last modified on 2019/04/22

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Basic information
Public title Phase II trial of Transarterial Chemoembolization using Drug-eluting bead for advanced HCC refractory to Lipiodol-TACE
Acronym TALENT study
Scientific Title Phase II trial of Transarterial Chemoembolization using Drug-eluting bead for advanced HCC refractory to Lipiodol-TACE
Scientific Title:Acronym TALENT study
Region
Japan

Condition
Condition advanced hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of DEB-TACE for patients with advanced HCC who have failed Lip-TACE
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes response rate (1 months)
Key secondary outcomes adverse events, progression-free survival, overall survival

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
Medicine
Interventions/Control_1 Transarterial chemoembolization using drug-eluting bead loaded epirubicin
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. Histologically or clinically confirmed hepatocellular carcinoma.
2. refractory to Lip-TACE
3. contraindication of surgery or ablation therapy
4. over 20 years old
5. BCLC stage A or B 6. Existing measurable hepatic lesion mRECIST is applicable.
7. ECOG Performance Status 0 or 1
8. Adequate organ functions: bone marrow, Heart, renal function (14 days before entry)
WBC(or Neutro) =>2,500/mm3 (=>1,000/mm3)
HGB =>8.5g/dl
Plt >=5.0x104/mm3
T-Bil <=2.5mg/dl
ALB =>2.8g/dl AST <= 5 times ULN
ALT <= 5 times ULN
Serum Cre <=1.5mg/dl
normal ECG
9. Child-Pugh A or B
10. previous Lip-TACE less than 5 times
11. Expected survival time over 8 weeks
12. Written informed consent
Key exclusion criteria 1) after HCC rupture
2) Reconstruction of the biliary tract history
3) severe ascites or pleural effusion
4) severe arterioportal shunt or arteriovenous shunt
5) Severe complication (Cardiac failure, Myocardial infarction, Pulmonary fibrosis, Interstitial pneumonia, Uncontrollable diabetic, Renal failure)
6) development of collateral feeding artery 7) Pregnant, nursing or possible pregnant woman
8) Heparic artery occlusion under CT angiography or angiography (Registration after qualification with CT angiography. Judging occlusion under angiography, including reservoir DAS, in case unqualified judgement with CT angiography) 9) Qualified ineligible patients being this clinical trial by responsible doctor
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Yamakado
Organization Mie University
Division name Department of Interventional Radiology
Zip code
Address 2-174 Edobashi, Tsu, Mie, Japan, 514-8507
TEL 059-232-1111
Email yama@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Nishiofuku
Organization Nara Medical University Hospital
Division name Radiology and IVR Center
Zip code
Address 840 Sijo-cho,kashihara-city,Nara,Japan
TEL 0744-22-3051
Homepage URL
Email hmn@naramed-u.ac.jp

Sponsor
Institute Clinical Research Group of the Japanese Society for Transcatheter Hepatic Arterial Embolization
Institute
Department

Funding Source
Organization The Japanese Society for Transcatheter Hepatic Arterial Embolization
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2014 Year 10 Month 17 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
2014 Year 09 Month 30 Day
Date of IRB
2014 Year 10 Month 01 Day
Anticipated trial start date
2014 Year 10 Month 17 Day
Last follow-up date
2019 Year 12 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
2014 Year 10 Month 17 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017976

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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