UMIN-CTR Clinical Trial

Basic information
Public title	A prospective randomized controlled trial of selective conventional TACE vs. drug-eluting beads TACE with epirubicin for patients with hepatocellular carcinoma
Acronym	A randomized controlled trial of selective conventional TACE vs. drug-eluting beads TACE for hepatocellular carcinoma
Scientific Title	A prospective randomized controlled trial of selective conventional TACE vs. drug-eluting beads TACE with epirubicin for patients with hepatocellular carcinoma
Scientific Title:Acronym	A randomized controlled trial of selective conventional TACE vs. drug-eluting beads 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 of selective conventional TACE and drug-eluting beads TACE 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

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	Medicine Device,equipment
Interventions/Control_1	Transcatheter arterial chemoembolization using epirubicin and drug-eluting beads
Interventions/Control_2	Transcatheter arterial chemoembolization using epirubicin/lipiodol emulsion
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 or total number>=4. 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	140

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masatoshi Isigami
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

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 01 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	2018 Year 02 Month 01 Day
Date of IRB	2018 Year 02 Month 28 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2020 Year 12 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	2018 Year 01 Month 15 Day
Last modified on	2021 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034406