UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of transcatheter arterial chemoembolization using combination of epirubicin and miriplatin for hepatocellular carcinoma -Prospective comparative study with transcatheter arterial chemoembolization using epirubicin-
Title of the study (Brief title)	TACE using combination of epirubicin&miriplatin for HCC - Prospective comparative study with TACE using epirubicin-
Region	Japan

Condition
Condition	Hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of trancatheter arterial chemoembolizaion (TACE) using combination of epirubicin and miriplatin for hepatocellular carcinoma and to compared with TACE using epirubicin.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Anti-tumor effect Safety
Key secondary outcomes	Tumor marker

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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
Interventions/Control_1	(TACE using combination of epirubicin and miriplatin) 70mg miriplatin suspended in lipiodol and 20mg epirubicin dissolved in contrast medium are mixed, the preparation is injected through the catheter selectively introduced into the hepatic artery. Amount of lipiodol was decided by total tumor diameter and amount of contrast medium was mixed with 1/2 lipiodol volume.
Interventions/Control_2	(TACE using epirubicin) 40mg epirubicin dissolved in contrast medium and lipiodol are mixed, the preparation is injected through the catheter selectively introduced into the hepatic artery. Amount of lipiodol was decided by total tumor diameter and amount of contrast medium was mixed with 1/2 lipiodol volume.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with typical HCC diagnosed by histological or clinical examinations. 2) Patients without candidate for hepatectomy and ablation therapy. 3) Patients who are able to undergo TACE. 4) Child-Pugh score of 7 or less. 5) Patients aged 20 years or over. 6) ECOG performance status of 0-2. 7) Patients with measurable target lesion on Modified RECIST. 8) Patients with at least 4 weeks interval from previous hepatectomy, ablation therapy and TACE. 9) The function of the major organ is kept as satisfied, and laboratory values meet the following criteria within 14 days before study entry. 1.White blood cell>=3,000/mm3 2.Platelet>=50,000/uL 3.Hemogrobin>=8.0g/dL 4.Total serum bilirubin=<2.0mg/dL 5.AST and ALT=<5 times upper limits of normal 6.Prothrombin time(%)>=50% 7.Serum creatinine=<2.0mg/dL 8.No abnormal findings requiring treatment in the electrocardiogram. 10) Patients who are expected to live more than 3 months. 11) Patients obtained written informed consent except following key exclusion criteria.
Key exclusion criteria	1) History of previous treatment by platinum drugs. 2) Extrahepatic metastasis. 3) Advanced vascular or biliary invasion (Vp3, Vp4, Vv3, B3, B4). 4) Severe arterio-portal shunt or arterio-venous shunt. 5) Difficult to perform transcatheter arterial chemotherapy. 6) History of the biliary tract reconstruction or treatment. 7) Patients with following severe complicating disease(except chronic hepatitis and liver cirrhosis). 1. Heart failure 2. Renal failure(GFR:<15mL/min/1.73m2) 3. Active infections(except viral hepatitis) 4. Active gastrointestinal bleeding 5. Active duplicative cancer 6. Hepatic encephalopathy or severe mental illness 8) Fever>=38.0 degrees Celsius. 9) History of hypersensitivity to iodine-containing contrast agent, gadolinium-containing contrast agent, epirubicin and platinum-containing drug. 10) Patients who are pregnant, lactating, suspected to be pregnant, or wish to become pregnant. 11) Patients who are concluded to be inappropriate to undergo TACE by angiography. 12) Patients who are concluded to be inappropriate to participate in this study by their physicians.
Target sample size	60

Research contact person
Name of lead principal investigator	Masaki Kaibori
Organization	Kansai Medical University
Division name	Department of Surgery
Address	2-3-1 Shinmachi, Hirakata, Osaka
TEL	072-804-0101
Email	kaibori@hirakata.kmu.ac.jp

Public contact
Name of contact person	Masaki Kaibori
Organization	Kansai Medical University
Division name	Department of Surgery
Address	2-3-1 Shinmachi, Hirakata, Osaka
TEL	072-804-0101
Homepage URL
Email	kaibori@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 10 Month 19 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 10 Month 15 Day
Anticipated trial start date	2012 Year 10 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 10 Month 19 Day
Last modified on	2016 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010705