UMIN-CTR Clinical Trial

Public title

Efficacy of transcatheter arterial chemoembolization (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to conventional TACE

Acronym

Efficacy of transcatheter arterial chemoembolization (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to conventional TACE

Scientific Title

Efficacy of transcatheter arterial chemoembolization (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to conventional TACE

Scientific Title:Acronym

Efficacy of transcatheter arterial chemoembolization (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to conventional TACE

Region

Japan

Condition

Multiple hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine	Hepato-biliary-pancreatic surgery	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess the efficacy of transcatheter arterial chemoembolizaion (TACE) with miriplatin for multiple hepatocellular carcinoma refractory or inappropriate to cisplatin or epirubicin -TACE.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

Response rate
(based on RECICL or mRECIST)

Key secondary outcomes

Progression free survival
Disease control rate
Safety
1y survival rate

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Miriplatin-TACE

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) HCC histologically or clinically confirmed
2) Patients with multiple HCCs that are diagnosed as stageII-IVA and are not indication for surgical resection or local ablation
3) Patients without severe tumor thrombosis in the portal vein, hepatic vein or the bile duct
*severe tumor thrombosis (Vp3, Vp4, Vv3)
4) Patients under Child-Pugh A or B
5) Patients under PS 0 or 1
6) Patients who fulfill following A) or B)
A) In active clinical trial (C-385, UMIN ID:UMIN000003162), refractory patients to cisplatin or epirubicin-TACE.
B) In active clinical trial (C-385, UMIN ID:UMIN000003162), inappropriate patients and patients who fulfill all of the selected criteria below
1.CRE<2.0mg/dl
(In active clinical trial, CRE=<1.2mg/dl)
2.WBC>=3000/mm3
3.Plt>=5x10^4/mm3
4.Hb>=8.0g/dl
5.T-Bil=<3.0mg/dl

Key exclusion criteria

1) Patients with another active cancer
2) Patients with extrahepatic metastasis
3) Patients with prior surgical reconstruction of the biliary tract or prior endoscopic treatment of ampulla of vater
4) Patients with clinically significant refractory ascites or pleural effusion
5) Patients with hepatic encephalopathy
6) Patients with severe co-morbidity such as cardiac failure and renal failure
7) Patients with a medical history of severe hypersensitivity
8) Patients who are pregnant, lactating or are suspected to be pregnant.
9) Patients who are concluded to be inappropriate to participate in this study by their physicians

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Etsuro Hatano

Organization

Graduate School of Medicine Kyoto University

Division name

Department of Surgery

Zip code

Address

54 Kawaharacho Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3608

Email

etsu@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yosuke Kasai

Organization

Graduate School of Medicine Kyoto University

Division name

Department of Surgery

Zip code

Address

54 Kawaharacho Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3608

Homepage URL

Email

shiryou@kuhp.kyoto-u.ac.jp

Institute

Department of Surgery, Graduate School of Medicine Kyoto University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学医学部附属病院(京都府)

Date of disclosure of the study information

2013

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2013

Year

03

Month

18

Day

Date of IRB

Anticipated trial start date

2013

Year

04

Month

01

Day

Last follow-up date

2016

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

03

Month

21

Day

Last modified on

2013

Year

09

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012029