UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005495
Receipt number R000006503
Scientific Title Transcatheter arterial infusion chemotherapy using cisplatin powder and iodized-oil for advanced hepatocellular carcinoma: a phase 2 study
Date of disclosure of the study information 2011/04/25
Last modified on 2015/04/24 13:24:50

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Transcatheter arterial infusion chemotherapy using cisplatin powder and iodized-oil for advanced hepatocellular carcinoma: a phase 2 study

Acronym

HCC-CDDP+Lipiodol-P2

Scientific Title

Transcatheter arterial infusion chemotherapy using cisplatin powder and iodized-oil for advanced hepatocellular carcinoma: a phase 2 study

Scientific Title:Acronym

HCC-CDDP+Lipiodol-P2

Region

Japan


Condition

Condition

HCC

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of the transcatheter arterial infusion chemotherapy using cisplatin powder and iodized-oil in patients with advanced HCC who are not candidates for surgical resection, percutaneous ablation, or TACE.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate (RR)

Key secondary outcomes

Safty
Tumor markers
Overall survival (OS)
6-months survival rate
1-year survival rate
Progression free survival (PFS)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Transcatheter arterial chemothherapy using CDDP powder and iodized-oil.

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



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, ablation therapy, and TACE.
3)BCLC stage B or C.
4)Child-Pugh score of 8 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 =< 1.5mg/dL
8.No abnormal findings requiring treatment in the electrocardiogram
10)Patients who are expected to live more than 3 months.
11)Patients who signed the informed consent to participate in this study.

Key exclusion criteria

1)History of previous treatment by platinum drugs.
2)Extrahepatic metastasis.
3)Advanced vascular or biliary invasion (Vp4,Vv3,B3,B4).
4)Sever 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
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, 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 participate in this study by their physicians.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruyuki Takaki

Organization

Mie University School of Medicine

Division name

Department of Radiology

Zip code


Address

2-174, Edobashi, Tsu, Mie

TEL

059-231-5029

Email

takaki-h@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Haruyuki Takaki

Organization

Mie University School of Medicine

Division name

Department of Radiology

Zip code


Address

2-174, Edobashi, Tsu, Mie

TEL

059-231-5029

Homepage URL


Email

takaki-h@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Japan Society of Transcatheter Hepatic Arterial Embolization Clinical Reserch Group

Institute

Department

Personal name



Funding Source

Organization

Japan Society of Transcatheter Hepatic Arterial Embolization Clinical Reserch Group

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

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

2011 Year 04 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2011 Year 02 Month 07 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 01 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

2011 Year 04 Month 24 Day

Last modified on

2015 Year 04 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006503


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name