UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015463 |
|---|---|
| Receipt number | 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 21:57:40 |
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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
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
hmn@naramed-u.ac.jp
Sponsor or person
Institute
Clinical Research Group of the Japanese Society for Transcatheter Hepatic Arterial Embolization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017976
