UMIN-CTR Clinical Trial

Public title

Balloon occluded transarterial chemoembolization using miriplatin in HCC: A Multicenter, Clinical Phase II study

Acronym

B-TACE study

Scientific Title

Balloon occluded transarterial chemoembolization using miriplatin in HCC: A Multicenter, Clinical Phase II study

Scientific Title:Acronym

B-TACE study

Region

Japan

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate effectiveness and safety of balloon occluded transarterial chemoembolization using miriplatin in HCC.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response rate in largest tumor (3 months after treatment)

Key secondary outcomes

Adverse events, progression-free survival, overall survival, response rate of HCC treated by B-TACE (3 months), achievement rate of B-TACE

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

Balloon occluded transarterial chemoembolization using miriplatin

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1). Histologically or clinically confirmed hepatocellular carcinoma. The largest tumor is<= 5cm. The number of HCC in the patient is within 4 (local recurrent lesion is not allowed).
2). Without major portal invasion (Vp3 or Vp4)
3). Target lesion is not treated.
4). Child-Pugh A or B
5). not the candidate of surgery
6). Adequate organ functions: bone marrow, Heart, renal function (14 days before entry)
Neutro =>1,500/mm3
HGB =>8.5g/dl
Plt >=5.0x104/mm3
T-Bil <=2.0mg/dl
AST <= 5 times ULN
ALT <= 5 times ULN
PT% > 50%
Serum Cre <=1.5 times ULN
7). Over 18 years old
8). ECOG Performance Status 0 or 1
9). Expected survival time over 12 weeks
10). Written informed consent

Key exclusion criteria

1) Bile duct injury(bile duct dilatation), reconstruction of the biliary tract history, history of endoscopic biliary treatment
2) Severe arterio-portal shunting
3) Severe arterial stenosis or obstruction in CECT or AAG
4) Severe ascites or pleural effusion
5) Major portal invation (Vp3 or Vp4)
6) Severe complication (cardiac failure, arrhythmia, angina pectoris, myocardial infarction within 6 months, double cancer, active infection, gastrointestinal bleeding, severe hepatic encephalopathy, severe allergya for
contrast media or medicine)
7) Pregnant, nursing or possible pregnant woman
8) Qualified ineligible patients being this clinical trial by responsible doctor

Target sample size

52

Name of lead principal investigator

1st name
Middle name
Last name	Koichiro Yamakado

Organization

Hyogo College Of Medicine College

Division name

Department of Radiology

Zip code

Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6111

Email

yamakado47@gmail.com

Name of contact person

1st name
Middle name
Last name	Akira Yamamoto

Organization

Osaka City Univercity

Division name

Department of Radiology

Zip code

Address

1-4-3, Asahi-machi,Abebo-ku, Osaka, Osaka

TEL

06-6645-3831

Homepage URL

Email

loveakirayamamoto@gmail.com

Institute

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

Other

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

2017

Year

10

Month

11

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

Preinitiation

Date of protocol fixation

2017

Year

09

Month

29

Day

Date of IRB

Anticipated trial start date

2017

Year

10

Month

26

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

10

Month

11

Day

Last modified on

2017

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033711