UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000017976