UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034333
Receipt number R000039145
Scientific Title The safety and efficacy of Lenvatinib for patients with unresectable hepatocellular carcinoma on practical medicine after the approval
Date of disclosure of the study information 2019/01/01
Last modified on 2022/04/04 15:08:33

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Basic information

Public title

The safety and efficacy of Lenvatinib for patients with unresectable hepatocellular carcinoma on practical medicine after the approval

Acronym

The safety and efficacy Lenvatinib on practical medicine

Scientific Title

The safety and efficacy of Lenvatinib for patients with unresectable hepatocellular carcinoma on practical medicine after the approval

Scientific Title:Acronym

The safety and efficacy Lenvatinib on practical medicine

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To estimate the safety and efficacy of Lenvatinib on practical medicine and to compare with the results and the REFLECT trial

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival

Key secondary outcomes

Objective response rate
Adverse events
Drug withdrawal
Drug interruption
Dose reduction
Dose intensity


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

unresectable hepatocellular carcinoma

Key exclusion criteria

Pregnant woman
Woman who may be pregnant

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Shinji
Middle name
Last name Katsushima

Organization

National Hospital Organization Kyoto Medical Center

Division name

Gastroenterology

Zip code

6128555

Address

Fukakusa-mukaibatakechou 1-1, Fushimi-ku, Kyoto, JAPAN

TEL

075-641-9161

Email

katsushima.shinji.ky@mail.hosp.go.jp


Public contact

Name of contact person

1st name Shinji
Middle name
Last name Katsushima

Organization

National Hospital Organization Kyoto Medical Center

Division name

Gastroenterology

Zip code

6128555

Address

Fukakusa-mukaibatakechou 1-1, Fushimi-ku, Kyoto, JAPAN

TEL

075-641-9161

Homepage URL


Email

katsushima.shinji.ky@mail.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization Kyoto Medical Center

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterology, National Hospital Organization Kyoto Medical Center

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

Kyoto Medical Center IRB

Address

Fukakusa-mukaibatakechou 1-1, Fushimi-ku, Kyoto, JAPAN

Tel

075-641-9161

Email

404-shoukaki@mail.hosp.go.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

2019 Year 01 Month 01 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

Terminated

Date of protocol fixation

2018 Year 05 Month 21 Day

Date of IRB

2018 Year 05 Month 22 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information

Overall survival are measured from the date of the initiation of Lenvatinib until the date of death from any cause.

Tumor assessments are down every 8weeks using dynamic CT or dynamic MRI.

Adverse events are graded according to CTCAE version 4.0.


Management information

Registered date

2018 Year 09 Month 30 Day

Last modified on

2022 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039145


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name