UMIN-CTR Clinical Trial

Public title

Bland Embolization for Treatment Refractory Liver Metastases

Acronym

BEATLE study

Scientific Title

Bland Embolization for Treatment Refractory Liver Metastases

Scientific Title:Acronym

BEATLE study

Region

Japan

Condition

Liver metastases

Classification by specialty

Hepato-biliary-pancreatic medicine

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of the transcatheter arterial embolization using microsphere for treatment refractory liver metastases

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Response rate (1 month)

Key secondary outcomes

Safety, Overall survival, Progression-free survival, Cancer type response rate

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 embolization using microsphere

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 liver metastases
2) Hypervascular
3) Treatment refractory
4) Max tumor can be evaluated with modified RECIST
5) Liver metastases seems to be the most important factor for prognosis
6) Child-Pugh class A
7) ECOG performance status: 0 or 1
8) Over 18 years old
9) Function of bone marrow, liver, and kidney are normal
10) Four weeks after the previous treatment
11) Expected survival time over 8 weeks
12) Written informed consent

Key exclusion criteria

1) Invasion to the portal vein (Vp3. Vp4)
2) History of the surgery or endoscopic treatment of the biliary tract
3) Treatment refractory pleural effusion or ascites
4) Severe arterioportal shunt or arteriovenous shunt
5) Severe stenosis or occlusion of the hepatic artery
6) History of the transcatheter arterial embolization/chemoembolization (TAE/TACE) using microsphere
7) Severe complication;
heart failure, angina pectoris, arrhythmia,
myocardial infarction
active infection
active gastrointestinal hemorrhage
hepatic encephalopathy, mental disorder
Iodine allergy, severe food allergy
8) Duplicate active cancer
9) Pregnant woman or woman who want to be pregnant
10) Qualified ineligible patients being this clinical trial by responsible doctor

Target sample size

27

Name of lead principal investigator

1st name	Koichiro
Middle name
Last name	Yamakado

Organization

Hyogo college of medicine

Division name

Radiology

Zip code

663-8501

Address

1-1 Mukogawa, Nishinomiya, Hyogo

TEL

0798-45-6362

Email

Ko-yamakado@hyo-med.ac.jp

Name of contact person

1st name	Miyoko
Middle name
Last name	Suzuki

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Clinical Research Management Center

Zip code

467-8601

Address

1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya

TEL

+81-(0)52-858-7215

Homepage URL

http://ncu-cr.jp/

Email

clinical_research@med.nagoya-cu.ac.jp

Institute

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

Institute

Department

Personal name

Organization

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

Nagoya City University Graduate School of Medical Sciences

Address

1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya

Tel

052-853-8276

Email

mshimohira@gmail.com

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

2015

Year

11

Month

18

Day

URL releasing protocol

http://thae.kenkyuukai.jp/special/?id=4036

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/33098022/

Number of participants that the trial has enrolled

25

Results

Twenty-five patients were enrolled in this study. Primary lesions were colorectal cancer in 12 patients, other cancer in 7, neuroendocrine tumor in 4, and sarcoma in 2. ORR and DCR were 52% and 72% in all patients, 42% and 75% in colorectal cancer patients, and 62% and 69% in other malignant tumor patients. Median survival time was 19 months in all patients. Median PFS time was 4 months in all patients. There were no grade-3 or -4 adverse events.

Results date posted

2021

Year

05

Month

24

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Patients with hypervascular liver metastases refractory to standard treatment

Participant flow

25 patients were enrolled

Adverse events

There were no grade-3 or -4 adverse events.

Outcome measures

objective response　rate
disease control rate
overall survival
progression-free survival
adverse events

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2015

Year

08

Month

14

Day

Date of IRB

2015

Year

11

Month

09

Day

Anticipated trial start date

2015

Year

11

Month

18

Day

Last follow-up date

2018

Year

03

Month

22

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

11

Month

18

Day

Last modified on

2021

Year

05

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022924

Single case data URL

Value
https://center6.umin.ac.jp/ice/22924