UMIN-CTR Clinical Trial

Public title

Randomized contorol trial of transarterial chemoinfusion with cisplatin-lipiodol susupension or miriplatin-lipiodol suspension for advanced HCC

Acronym

Randomized contorol trial of transarterial chemoinfusion for advanced HCC

Scientific Title

Randomized contorol trial of transarterial chemoinfusion with cisplatin-lipiodol susupension or miriplatin-lipiodol suspension for advanced HCC

Scientific Title:Acronym

Randomized contorol trial of transarterial chemoinfusion for advanced HCC

Region

Japan

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To compare with the efficacy and safety on trasarterial chemoinfusion between miriplatin-lipiodol suspension and cisplatin-lipiodol suspension with advanced HCC

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Response rate

Key secondary outcomes

Overall survival
Safety

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Miriplatin-lipiodol suspension group:Powdered miriplatin(70mg) suspended in lipiodol(6ml) is injected through the catheter selectively introduced into the hepatic artery,The doses of suspension are determined according to filled a tumor artery.and upper limitation is 140mg as miriplatin.
If the patients need repeated therapy ,they are treated at the interval of 4weeks

Interventions/Control_2

Cisplatin-lipiodol suspension group:Powdered cisplatin(50mg) suspended in lipiodol(6ml) is injected through the catheter selectively introduced into the hepatic artery,The doses of suspension are determined according to filled a tumor artery.and upper limitation is 100mg as cisplatin.
If the patients need repeated therapy ,they are treated at the interval of 4weeks

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Histologically or clinically comfirmed Hepatocellular carcinoma
2)Patients diagnosed as stage2-3
3)Interval of 4 weeks or over between last treatment and present therapy
4)Child-pugh is A or B
5)No indication for surgical resection or local ablation
6)PS is 0,1 or 2
7)Sufficient functions of main organ(bone marrow,kidney,heart)and conditions filled a following criteria
1 WBC>=2,000 /mm3,<=10,000 /mm3
2 Plt>=50,000 /mm3
3 Hb>=8.0 g/dL
4 T-Bil<=3.0 mg/dL
5 PT>=50%
6 Creatinine<=1.5 mg/dL
7 BUN<=35 mg/dL
8)Age is more than 20 years old and below 80 years old
9)Patients obtained written infoemed consent

Key exclusion criteria

1)Patienta with sever co-morbidity such as cardiac failure or renal failure
2)Patienta with a medical history of severe hypersensitivity
3)Patients who are pregnant,lactating or are suspected to be a pregnant
4)Patients who are concluded to be inappropriate to participate in this study by their physitians

Target sample size

100

Name of lead principal investigator

1st name	Koji
Middle name
Last name	Takai

Organization

Gifu University Hospital

Division name

First Department of Internal Medicine

Zip code

501-1194

Address

1-1 Yanagido Gifu 501-1194

TEL

058-230-6000

Email

koz@gifu-u.ac.jp

Name of contact person

1st name	Koji
Middle name
Last name	Takai

Organization

Gifu University Hospital

Division name

First Department of Internal Medicine

Zip code

5011194

Address

yanagido1-1,gifu,gifu

TEL

058-230-6000

Homepage URL

Email

koz@gifu-u.ac.jp

Institute

First Department of Internal Medicine,Gifu University Hospital

Institute

Department

Personal name

Organization

First Department of Internal Medicine,Gifu University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

IRB Gifu medical university

Address

1-1 Yanagido Gifu 501-1194

Tel

058-230-6000

Email

gjme00004@jim.gifu-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岐阜市民病院（岐阜県）　岐阜県総合医療センター（岐阜県）　中濃厚生病院（岐阜県）

Date of disclosure of the study information

2010

Year

05

Month

01

Day

URL releasing protocol

2015 May;45(5):514-22. doi: 10.1111/hepr.12376. Epub 2014 Jul 24.

Publication of results

Published

URL related to results and publications

2015 May;45(5):514-22. doi: 10.1111/hepr.12376. Epub 2014 Jul 24.

Number of participants that the trial has enrolled

98

Results

The 1-year survival rates in the cisplatin and miriplatin groups were 84.0% and 77.7%, and the 2-year survival rates were 60.0% and 51.8% respectively. (P = 0.905).The 1-year survival rates in the cisplatin and miriplatin groups with TAI alone were 71.4% and 71.4%, and the 2-year survival rates cannot be calculated yet. (P = 0.695).TE evaluation, the 1-year survival rates in TE3+4 and TE1+2 groups were 100% and 62.1%, and the 2-year survival rates were 66.7% and 33.1% respectively. (P = 0.0263).

Results date posted

2021

Year

10

Month

13

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

diagnosis of HCC by histology or contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI)

Participant flow

After admission, patients were randomly assigned to either the cisplatin or miriplatin group before undergoing angiography. Balanced randomization was carried out by employing index factors of etiology, sex, age, primary or recurrent disease, TACE or TAI, and previous therapy.

Adverse events

Incidences of any adverse event were 67.3% (33/49) in the cisplatin group and 63.3% (31/49) in the miriplatin group (P=0.6712, Table 5). No major complications of grade 4 or higher occurred in either group. Grade 3 nausea occurred in 1 patient in the cisplatin group. Anaphylaxis occurred in 1 patient in each group, both during the second session. Both cases fulfilled all major criteria of the definition by Ruggeberg JU, et al 18 for the diagnosis of anaphylactic shock. The amount of drug at the first session was 100 mg of cisplatin and 75 mg of miriplatin. Each patient continued TACE with another agent. Diphasic fever appeared in 1 patient in the cisplatin group and in 5 patients in the miriplatin group (P=0.079). No other differences were found between the groups for each effect (Table 5).

Outcome measures

The primary endpoint was the TE 3 months after initial TACE or TAI, and the secondary endpoint was overall survival.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2010

Year

04

Month

01

Day

Date of IRB

2010

Year

04

Month

23

Day

Anticipated trial start date

2010

Year

05

Month

01

Day

Last follow-up date

2015

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

04

Month

05

Day

Last modified on

2021

Year

10

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004155