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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038867
Receipt No. R000044300
Scientific Title Sequential therapy for hepatocellular carcinoma -Real world evidence of TKI in prospective observational study-
Date of disclosure of the study information 2020/01/01
Last modified on 2020/06/11

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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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