UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000009149
Receipt number	R000010705
Scientific Title	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-
Date of disclosure of the study information	2012/10/19
Last modified on	2016/04/19 09:36:44

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Basic information

Public title

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-

Acronym

TACE using combination of epirubicin&miriplatin for HCC
- Prospective comparative study with TACE using epirubicin-

Scientific Title

Scientific Title:Acronym

TACE using combination of epirubicin&miriplatin for HCC
- Prospective comparative study with TACE using epirubicin-

Region

Japan

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

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

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

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

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

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Masaki Kaibori

Organization

Kansai Medical University

Division name

Department of Surgery

Zip code

Address

2-3-1 Shinmachi, Hirakata, Osaka

TEL

072-804-0101

Email

kaibori@hirakata.kmu.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Masaki Kaibori

Organization

Kansai Medical University

Division name

Department of Surgery

Zip code

Address

2-3-1 Shinmachi, Hirakata, Osaka

TEL

072-804-0101

Homepage URL

Email

kaibori@hirakata.kmu.ac.jp

Sponsor or person

Institute

Kansai Medical University

Institute

Department

Personal name

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)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 19 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

Open public recruiting

Date of protocol fixation

2012 Year 10 Month 15 Day

Date of IRB

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

Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010705

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name