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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026897
Receipt No. 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 2019/04/12

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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
Institute Nagoya University Hospital
Department of Gastroenterology and Hepatology
Institute
Department

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 Preinitiation
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
2019 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.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


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