UMIN-CTR Clinical Trial

Public title

Transcatheter arterial infusion chemotherapy using miriplatin in patients with advanced hepatocellular carcinoma: Prospective randomized study, Lip-TAI vs. Lip+DSM-TAI

Acronym

TAI using miriplatin: Lip-TAI vs. Lip+DSM-TAI

Scientific Title

Transcatheter arterial infusion chemotherapy using miriplatin in patients with advanced hepatocellular carcinoma: Prospective randomized study, Lip-TAI vs. Lip+DSM-TAI

Scientific Title:Acronym

TAI using miriplatin: Lip-TAI vs. Lip+DSM-TAI

Region

Japan

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We investigate the efficacy of lipiodol+degradable starch microspheres (DSM)-transarterial infusion chemotherapy (TAI) using miriplatin for advanced HCC in a randomized trial between lipiodol-TAI and lipiodol+DSM-TAI.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Time-to-progression

Key secondary outcomes

Tumor response, overall survival, and safety

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Lipiodol-TAI using miriplatin
The injection of Lipiodol was limited to 6 mL.

Interventions/Control_2

Lipiodol+DSM-TAI
After the administration of emulsion using miriplatin and Lipiodol, DSM was injected. The injection of Lipiodol was limited to 6 mL.

Interventions/Control_3

Lipiodol-TAI using miriplatin
The injection of Lipiodol was limited to 10 mL.

Interventions/Control_4

Lipiodol+DSM-TAI
After the administration of emulsion using miriplatin and Lipiodol, DSM was injected. The injection of Lipiodol was limited to 10 mL.

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) Histologically proven or clinically diagnosed hepatocellular carcinoma.
2) Locally nodular disease without extrahepatic metastasis.
3) No indication for surgical resection and local ablation.
4) No vascular tumor thrombosis (portal vein, hepatic vein, and bile duct).
5) Not remarkable findings of A-V shunt and/or A-P shunt.
6) The emulsion of miriplatin and Lipiodol<= 6 mL: The maximum tumor diameter <= 5 cm and the tumor number <= 5 nodules in the liver.
The emulusion of miriplatin and lipiodol > 6 mL: The maxmum tumor diameter <= 10 cm and the tumor number <= 10 nodules in the liver.
7) Do not have effect of pervious treatment.
8) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
9) Child-Pugh score of A or B.
10) Adequate organ and marrow function listed below.
(1) leukocyte count >= 3000/mm3
(2) platelet count >= 50000/mm3
(3) hemoglobin level >= 9.5 g/dL
(4) total bilirubin <= 3.0 mg/dL
(5) serum albumin 2.5-3.5 g/dL
(6) serum creatinine level normal upper level
(7) BUN <= 25 mg/dL
11) Age >= 20 years old
12) Life expectancy at least 3 months.

Key exclusion criteria

1) Parients with severe complicating disease except chronic hepatitis or liver cirrhosis.
2) Patients with active double cancer.
3) The patient with the anamnesis of the hypersensitivity.
4) A pregnant woman, or woman who may pregnant and who are nursing.
5) Patients who were disqualified by doctor in attendance.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Takahiro Yamasaki

Organization

Yamaguchi Univercity Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

Address

1-1-1 Minamikogushi, Ube, Yamaguchi

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Yamaguchi Univercity Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

Address

1-1-1 Minamikogushi, Ube, Yamaguchi

TEL

Homepage URL

Email

Institute

Department of Gastroenterology and Hepatology, Yamaguchi Univercity Graduate School of Medicine

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

Date of disclosure of the study information

2010

Year

11

Month

10

Day

URL releasing protocol

Publication of results

Partially published

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

Terminated

Date of protocol fixation

2010

Year

10

Month

07

Day

Date of IRB

Anticipated trial start date

2010

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

11

Month

09

Day

Last modified on

2017

Year

05

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005404