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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002435
Receipt No. 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

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

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
URL(English) https://upload.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


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