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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017953
Receipt No. R000020805
Scientific Title New assessment of therapeutic response to sorafenib for advanced hepatocellular carcinoma
Date of disclosure of the study information 2015/06/19
Last modified on 2017/06/20

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Basic information
Public title New assessment of therapeutic response to sorafenib for advanced hepatocellular carcinoma
Acronym New assessment of therapeutic response to sorafenib for advanced hepatocellular carcinoma
Scientific Title New assessment of therapeutic response to sorafenib for advanced hepatocellular carcinoma
Scientific Title:Acronym New assessment of therapeutic response to sorafenib for advanced hepatocellular carcinoma
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Although sorafenib has been shown to have significant survival advantages in patients with HCC, RECIST 1.1 may underestimate the efficacy because of modest tumor shrinkage. The aim of this study was to establish an objective radiological evaluation method for anti-tumor response of sorafenib with regard to survival, using LMS, an automated software to measure lesion size, volume and Hounsfield unit (HU) density.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Child-Pugh class A
2) Barcelona Clinic Liver Cancer stage C
3) ECOG performance status 0 or 1
Key exclusion criteria No follow-up CT images are available
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunori Kawaguchi
Organization Saga-Ken Medical Centre Koseikan
Division name Department of Hepatobiliary and Pancreatology
Zip code
Address 400 Nakabaru. Kase-machi, Saga-shi, Saga 840-8571, Japan
TEL 0952-24-2171
Email kawaguy222@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Kawaguchi
Organization Saga-Ken Medical Centre Koseikan
Division name Department of Hepatobiliary and Pancreatology
Zip code
Address 400 Nakabaru. Kase-machi, Saga-shi, Saga 840-8571, Japan
TEL 0952-24-2171
Homepage URL
Email kawaguy222@gmail.com

Sponsor
Institute Saga-Ken Medical Centre Koseikan
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Canon Inc.
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
2015 Year 06 Month 19 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
2014 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study: Exploring of new imaging biomarkers for survival among the patients under sorafenib treatment since it was commercially available in 2008. Follow-up CT scans were taken every 2-3 mo for evaluation. Such biomarkers may include longest diameter, lesion volume and HU density.
Prospective study: Based on the best results of retrospective study, prediction/classification ability for survival will be validated by supporting physicians' medication decision on sorafenib. Follow-up CT scans will be taken every 2-3 mo for evaluation.

Management information
Registered date
2015 Year 06 Month 17 Day
Last modified on
2017 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020805

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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