UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026897
Receipt number R000030857
Scientific Title A prospective randomized controlled trial of selective conventional TACE vs. balloon occluded TACE with epirubicin for hepatocellular carcinoma
Date of disclosure of the study information 2017/04/10
Last modified on 2020/12/23 12:27:12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A prospective randomized controlled trial of selective conventional TACE vs. balloon occluded TACE with epirubicin for hepatocellular carcinoma

Acronym

A randomized controlled trial of selective conventional TACE vs. balloon occluded TACE for hepatocellular carcinoma

Scientific Title

A prospective randomized controlled trial of selective conventional TACE vs. balloon occluded TACE with epirubicin for hepatocellular carcinoma

Scientific Title:Acronym

A randomized controlled trial of selective conventional TACE vs. balloon occluded TACE for hepatocellular carcinoma

Region

Japan


Condition

Condition

Patients with hepatocellular carcinoma
who are scheduled to underwent TACE

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare local complete response o
f selective conventional TACE and balloon occluded TACE with emulsion of lipiodol/epirubicin and gelatine particle for hepatocellular carcinoma

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Tumor Response at 3 month after TACE

Key secondary outcomes

Adverse events
Success rate of TACE
Tumor Response based on location


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Micro balloon catheter

Interventions/Control_2

Microcatheter

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 proven or clinically diagnosed hepatocellular carcinoma.
2. No prospective candidate for hepatectomy,
liver transplantation, or local ablation therapy (judged by investigators).
3. Hypervascular lesion showing enhancement in the early phase on CT or MRI with bolus contrast injection.
4. Measurable HCC nodules in which TACE is planned.
5. No previous treatment for HCC nodules in which TACE is planned.
6. Without tumor thrombosis in main portal branch or portal trunk.
7. Performance status (ECOG) of 0 to 2.
8. Child Pugh class A or B.
9. Maximum HCC size <=5cm and total number<=3.
10. No major organ failure and all the laboratory data, below are conserved.
1) T.Bil<=3.0 mg/dL
2) WBC>=3,000/mm3
3) PLT>=50,000/mm3
11. Age of 20 years or over.
12. Written informed consent.

Key exclusion criteria

1. Extrahepatic metastasis.
2. Ruptured HCC nodules in which TACE is planned.
3. Prior surgical reconstruction or endoscopic treatment of the biliary tract.
4. Severe arterio portal or arterio venous shunts in the liver.
5. Refractory ascites or pleural effusion.
6. Allergy to contrast medium that precludes angiography.
7. Previously registered patients in this study.
8. Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing or able to use medically acceptable forms of contraception.
9. Comorbid diseases as cardiac failure, recent myoinfarction, renal failure, active infection, active gastrointestinal bleeding, active associated cancers, hepatic encephalopathy or uncontrolled psychologic disorders, and serious allergy to medicine.
10. Not eligible because of safety issues judged by investigators.

Target sample size

164


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masatoshi Ishigami

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-2169

Email

masaishi@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Teiji Kuzuya

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-2169

Homepage URL


Email

tkuzuya@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Hospital
Department of Gastroenterology and Hepatology

Institute

Department

Personal name



Funding Source

Organization

Nagoya University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

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

名古屋大学医学部附属病院(愛知県)


Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 10 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

Terminated

Date of protocol fixation

2017 Year 04 Month 10 Day

Date of IRB

2017 Year 01 Month 15 Day

Anticipated trial start date

2017 Year 04 Month 10 Day

Last follow-up date

2020 Year 03 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

2017 Year 04 Month 07 Day

Last modified on

2020 Year 12 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030857


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name