UMIN-CTR Clinical Trial

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

advanced hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

response rate (1 months)

Key secondary outcomes

adverse events, progression-free survival, overall survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

The Japanese Society for Transcatheter Hepatic Arterial Embolization

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

10

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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