UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033757
Receipt number R000038506
Scientific Title Impact of sarcopenia in lenvatinib treatment for hepatocellular carcinoma; A prospective observational study
Date of disclosure of the study information 2018/08/16
Last modified on 2022/08/20 17:03:46

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Basic information

Public title

Impact of sarcopenia in lenvatinib treatment for hepatocellular carcinoma; A prospective observational study

Acronym

Impact of sarcopenia in lenvatinib treatment for hepatocellular carcinoma; A prospective observational study

Scientific Title

Impact of sarcopenia in lenvatinib treatment for hepatocellular carcinoma; A prospective observational study

Scientific Title:Acronym

Impact of sarcopenia in lenvatinib treatment for hepatocellular carcinoma; A prospective observational study

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarifty the impact of sarcopenia in lenvatinib treatment for hepatocellular carcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression free survival

Key secondary outcomes

Overall survival
Objective response
Time to progression Child-Pugh B
Adverse event


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

1)HCC diagnosed by typical findings of radiological findings or histologically proven by biopsy
2)No indications for hepatic surgical resection and radiofrequency ablation
3)Measurable lesion detected
4)Child-Pugh class A
5)Performance status 0-1
6)adequate bone marrow
7)adequate renal function

Key exclusion criteria

1)Child-Pugh class B or C
2)Performance status 2 or more
3)Patients with obvious invasion of the bile duct, or invasion at the main portal vein
4)Patients with 50% or higher liver occupation

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Takeshi
Middle name
Last name Hatanaka

Organization

Saiseikai Maebashi Hospital

Division name

Department of Gastroenterology

Zip code

371-0821

Address

Kamishinden-machi 564-1, Maebashi, Gunma

TEL

027-252-6011

Email

hatanaka@qk9.so-net.ne.jp


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Hatanaka

Organization

Saiseikai Maebashi Hospital

Division name

Saiseikai Maebashi Hospital

Zip code

371-0821

Address

Kamishinden-machi 564-1, Maebashi, Gunma

TEL

027-252-6011

Homepage URL


Email

hatanaka@qk9.so-net.ne.jp


Sponsor or person

Institute

Saiseikai Maebashi Hospital

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

The institutional review board

Address

Kamishinden-machi 564-1, Maebashi, Gunma

Tel

027-252-6011

Email

te-yoshinaga@maebashi.saiseikai.or.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 08 Month 16 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 07 Month 30 Day

Date of IRB

2018 Year 08 Month 13 Day

Anticipated trial start date

2018 Year 08 Month 17 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2018 Year 08 Month 15 Day

Last modified on

2022 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038506


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name