UMIN-CTR Clinical Trial

Basic information
Public title	Sequential therapy for hepatocellular carcinoma -Real world evidence of TKI in prospective observational study-
Acronym	HAMRET study
Scientific Title	Sequential therapy for hepatocellular carcinoma -Real world evidence of TKI in prospective observational study-
Scientific Title:Acronym	HAMRET study
Region	Japan

Condition
Condition	hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will conduct the prospective observational study to investigate the effectiveness for each sequential therapy in Japanese unresectable HCC patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival from 1st line treatment (including subsequent therapies)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	#1.Diagnosed with HCC histologically or clinically (image diagnosis and tumor marker) #2.Scheduled for systemic therapy for HCC #3.Patients who obtained written informed consent for this clinical study
Key exclusion criteria	#1.Patients with a past history of treatment for systemic therapy #2.Patients participating in another interventional clinical trials
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Tomoharu Middle name Last name Yoshizumi
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Science, Graduate School of Medical Sciences
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-642-5466
Email	tomyoshi@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Shinji Middle name Last name Itoh
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Science, Graduate School of Medical Sciences
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-642-5466
Homepage URL
Email	itoshin@surg2.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization	Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyushu University Ethics Review Board
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel	092-641-1151
Email	byssien@jimu.kyushu-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

九州大学病院（福岡県） 宗像医師会病院（福岡県） 福岡大学病院（福岡県） 独立行政法人国立病院機構九州医療センター（福岡県） 独立行政法人国立病院機構九州がんセンター（福岡県） 済生会福岡総合病院（福岡県） 地方独立行政法人福岡市立病院機構福岡市民病院（福岡県） 北九州市立医療センター（福岡県） 独立行政法人地域医療機能推進機構九州病院（福岡県） 飯塚病院（福岡県） 田川市立病院（福岡県） 佐賀県医療センター好生館（佐賀県） 長崎大学病院（長崎県） 独立行政法人国立病院機構長崎医療センター（長崎県） 熊本大学病院（熊本県） 医療法人創起会 くまもと森都総合病院（熊本県） 大分赤十字病院（大分県） 鹿児島大学病院（鹿児島県） 琉球大学病院（沖縄県） 徳島大学病院（徳島県） 愛媛県立中央病院（愛媛県） 広島赤十字・原爆病院（広島県） 群馬大学医学部附属病院（群馬県） 千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2020 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	Open public recruiting
Date of protocol fixation	2019 Year 11 Month 15 Day
Date of IRB	2020 Year 02 Month 13 Day
Anticipated trial start date	2020 Year 01 Month 15 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

#1.Progression free survival, ratio of response rate and disease control rate of each treatment regimen at each treatment line #2.Drug exposure (initial dose, duration of treatment and dose intensity) of each treatment regimen at each treatment line #3.Time to treatment failure and post-progression survival of each treatment regimen at each treatment line #4.Transition rate of subsequent line of each 1st line treatment #5.Sub-group analyses described in study protocol

Management information
Registered date	2019 Year 12 Month 12 Day
Last modified on	2020 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044300

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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