UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035136
Receipt number R000039643
Scientific Title The efficacy of molecular targeted therapy for unresectable hepatocellular carcinoma
Date of disclosure of the study information 2018/12/04
Last modified on 2019/06/05 14:32:21

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Basic information

Public title

The efficacy of molecular targeted therapy for unresectable hepatocellular carcinoma

Acronym

The efficacy of molecular targeted therapy for liver cancer

Scientific Title

The efficacy of molecular targeted therapy for unresectable hepatocellular carcinoma

Scientific Title:Acronym

The efficacy of molecular targeted therapy for liver cancer

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The evaluation of efficacy and side effect of molecular targeted therapy for hepatocellular carinoma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall suruvival

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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Cases that the molecular targeting drug was induced according to the eligibility criteria of each medicine.

Key exclusion criteria

Cases which treatment was not consistent with a clinical guideline.
Cases hard to be followed up.
Cases the attending physician judges inappropriate as a subject of the current study.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Takai

Organization

Kyoto University

Division name

Department of Gastroenterology and Hepatology

Zip code

606-8507

Address

54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto

TEL

075(751)4319

Email

atsushit@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Takai

Organization

Kyoto University

Division name

Department of Gastroenterology and Hepatology

Zip code

606-8507

Address

Kyoto

TEL

075(751)4319

Homepage URL


Email

atsushit@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto 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

Kyoto University Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto

Tel

075(753)4680

Email

ethcom@kuhp.kyoto-u.ac.jp


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

2018 Year 12 Month 04 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

2018 Year 11 Month 05 Day

Date of IRB

2018 Year 11 Month 05 Day

Anticipated trial start date

2018 Year 12 Month 04 Day

Last follow-up date

2023 Year 12 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Not in particular


Management information

Registered date

2018 Year 12 Month 04 Day

Last modified on

2019 Year 06 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039643


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name