UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038867
Receipt number 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 2021/12/13 09:16:08

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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 or person

Institute

Kyushu Study group of Clinical Cancer

Institute

Department

Personal name



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)
社会医療法人製鉄記念八幡病院(福岡県)
久留米大学病院(福岡県)
産業医科大学病院(福岡県)
佐賀大学医学部附属病院(佐賀県)
宮崎大学医学部附属病院(宮崎県))


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

2021 Year 12 Month 13 Day



Link to view the page

Value
https://center6.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