UMIN-CTR Clinical Trial

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
Institute	National Hospital Organization Kyoto Medical Center
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039145