UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009107
Receipt number R000010679
Scientific Title A clinical study on safety and efficacy of combined intraarterial cisplatin and 5-fluorouracil with systemic pegylated interferon alfa-2b for advanced hepatocellular carcinoma
Date of disclosure of the study information 2012/10/13
Last modified on 2012/11/08 13:19:59

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Basic information

Public title

A clinical study on safety and efficacy of combined intraarterial cisplatin and 5-fluorouracil with systemic pegylated interferon alfa-2b for advanced hepatocellular carcinoma

Acronym

A combination therapy of CDDP / 5-FU / PEG-IFN alfa-2b for advanced hepatocellular carcinoma. : study of safety and efficacy

Scientific Title

A clinical study on safety and efficacy of combined intraarterial cisplatin and 5-fluorouracil with systemic pegylated interferon alfa-2b for advanced hepatocellular carcinoma

Scientific Title:Acronym

A combination therapy of CDDP / 5-FU / PEG-IFN alfa-2b for advanced hepatocellular carcinoma. : study of safety and efficacy

Region

Japan


Condition

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate on safety and efficacy of combination therapy of intraarterial cisplatin / 5-fluorouracil with systemic pegylated interferon alfa-2b in patients with advanced hepatocellular carcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficacy

Key secondary outcomes



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

Cisplatin (IA-call; Nippon Kayaku Company Ltd.,Tokyo,Japan) : Administrated at a dose of 20mg/m2 by hepatic arterial infusion on days 1 and 15. 5-FU (Kyowa Hakko, Tokyo, Japan) : Administrated at a dose of 250mg/body into hepatic artery for 5 h via mechanical infusion pump on days 1-5 of every a week. PEG-IFN alpha-2b (PegIntron; Schering-Plough, Osaka, Japan) :Administrated at a dose of 50-100ug/body in subcutaneously on day 1 of every a week. One treatment cycle lasts 4 weeks and the withdrawal period is 2 weeks to 4 weeks.

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Age 20-70 years
2.Histologically or clinically confirmed hepatocellular carcinoma
3.Patients with vascular invasion than Vp3
4.Written informed consent was obtained
5.Granulocyte>1500/mm3
6.Hemoglobin>8.5g/dL
7.AST>100
8.ALT>100
9.Total serum bilirubin<2mg/dL
10.Platelet count>80000/uL
11.Serum creatinine<1.5mg/dL
12.PS 0-1

Key exclusion criteria

1. Pregnant or breast-feeding patients.
2. Patients with hypersensitivity to Pt-drug and IFN
3. Severe complication
4. Patients with interstitial pneumonia or a history
5. Patients with central nervous system disorders , the depression or a history
6. Inappropriate patients for this study judged by physicians.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiro Kasai

Organization

Iwate Medical University

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code


Address

Uchimaru 19-1, Morioka, Iwate 020-8505, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Iwate Medical University

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code


Address


TEL


Homepage URL


Email

kaz-k@yc4.so-net.ne.jp


Sponsor or person

Institute

Iwate Medical University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

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

2012 Year 10 Month 13 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 13 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 13 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 13 Day

Last modified on

2012 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010679


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name