UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002435
Receipt number R000002980
Scientific Title Assessment of a combination therapy with Candesartan and Celecoxib for patients with advanced hepatocellular carcinoma after transhepatic arterial chemoembolization.
Date of disclosure of the study information 2009/09/02
Last modified on 2012/03/05 09:38:03

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Basic information

Public title

Assessment of a combination therapy with Candesartan and Celecoxib for patients with advanced hepatocellular carcinoma after transhepatic arterial chemoembolization.

Acronym

Phase 2 randomized trial of a combination therapy with Candesartan and Celecoxib for advanced HCC patients

Scientific Title

Assessment of a combination therapy with Candesartan and Celecoxib for patients with advanced hepatocellular carcinoma after transhepatic arterial chemoembolization.

Scientific Title:Acronym

Phase 2 randomized trial of a combination therapy with Candesartan and Celecoxib for advanced HCC patients

Region

Japan


Condition

Condition

unresectable advanced hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to assess the efficacy of a combination therapy with Celecoxib and Candesartan for unresectable advanced HCC patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Time to progression

Key secondary outcomes

Survival period


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Celecoxib and Candesartan

Interventions/Control_2

plasebo

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) HCC patients treated with TACE
2) Serum creatinine; less than 1.5 mg/dl, WBC; more than 2000, Total bilirubine; less than 3.0 mg/dl.
3) Performance status; ECOG 0-2
4) Liver damage; Child-Pugh class A or B
5) Patients without any influences of previous treatment.

Key exclusion criteria

1) pregnant woman, patients with severe thrombosis in past 6 months, patients with past history of peptic ulcer.
2) patients less than 120 mmHg of systolic blood pressure

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michio Sata

Organization

Kurume University, School of Medicine

Division name

Department of Medicine, Division of Gastroenterology

Zip code


Address

67 Asahi-machi, Kurume City, Japan

TEL

0942-31-7561

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takuji Torimura

Organization

Kurume University, School of Medicine

Division name

Department of Medicine, Division of Gastroenterology

Zip code


Address

67 Asahi-machi, Kurume City, Japan

TEL

0942-31-7561

Homepage URL


Email

tori@med.kurume-u.ac.jp


Sponsor or person

Institute

Kurume University, School of Medicine,Department of Medicine, Division of Gastroenterology

Institute

Department

Personal name



Funding Source

Organization

Kurume University, School of Medicine,Department of Medicine, Division of Gastroenterology

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

久留米大学医学部内科学講座消化器内科部門


Other administrative information

Date of disclosure of the study information

2009 Year 09 Month 02 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

2008 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 09 Month 01 Day

Last follow-up date

2011 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 09 Month 02 Day

Last modified on

2012 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002980


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name