UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010001
Receipt number R000011709
Scientific Title Retrospective observational study to investigate the predictive factors about the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.
Date of disclosure of the study information 2013/02/08
Last modified on 2015/03/02 20:06:48

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Basic information

Public title

Retrospective observational study to investigate the predictive factors about the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.

Acronym

Retrospective observational study to investigate the predictive factors about the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.

Scientific Title

Retrospective observational study to investigate the predictive factors about the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.

Scientific Title:Acronym

Retrospective observational study to investigate the predictive factors about the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Investigate the predictive factors about the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The clinicopathological factors related to time to progression of unresectable advanced hepatocellular carcinoma.patients treated with sorafenib.

Key secondary outcomes

The clinicopathological factors related to overall survival of unresectable advanced hepatocellular carcinoma patients treated with sorafenib.
The clinicopathological factors to predict serious adverse effects caused by sorafenib.


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with unresectable advanced hepatocellular carcinoma treated with sorafenib.

Key exclusion criteria

none

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Namiki Izumi

Organization

Musashino Red Cross Hospital

Division name

Division of Gastroenterology and Hepatology

Zip code


Address

1-26-1, Kyonancho, Musashino, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yukio Osaki

Organization

Osaka Red Cross Hospital

Division name

Depertment of Gastroenterology and Hepatology

Zip code


Address

5-30, Fudegasaki-cho, Tennoji-ku, Osaka

TEL


Homepage URL


Email



Sponsor or person

Institute

Japanese Red Cross Liver Study Group

Institute

Department

Personal name



Funding Source

Organization

Ministry ofHealth, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Genome Biology

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

武蔵野赤十字病院, 大阪赤十字病院, その他全国赤十字病院


Other administrative information

Date of disclosure of the study information

2013 Year 02 Month 08 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

This study included 259 males and 57 females with a median age of 70 years, of which 191 (60.4%) were classified as Barcelona Clinic Liver Cancer stage C, and 271 (85.8%) had Child-Pugh class A liver function. The median overall survival time was 307 days and progression-free survival time was 109 days. According to the modified Response Evaluation Criteria In Solid Tumours, four patients achieved a complete response, 51 achieved a
partial response, 136 had stable disease and 125 had progressive disease. Multivariate analysis identified female gender (P = 0.003) and decreased serum
AFP level after 1 month (P = 0.042) as independent predictors of a complete
or partial response.

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

Main results already published

Date of protocol fixation

2012 Year 05 Month 15 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 22 Day

Last follow-up date

2013 Year 10 Month 31 Day

Date of closure to data entry

2013 Year 12 Month 31 Day

Date trial data considered complete

2014 Year 01 Month 15 Day

Date analysis concluded

2014 Year 03 Month 31 Day


Other

Other related information

To investigate the predictive factors on the efficacy of sorafenib therapy for unresectable advanced hepatocellular carcinoma.
To perform genomic analyses on patients` tumor tissue obtained by liver biopsy before sorafenib administration, and to investigate biomarkers related to clinical course including OS, PFS and adverse effects.


Management information

Registered date

2013 Year 02 Month 08 Day

Last modified on

2015 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011709


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name