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 | 2024/10/25 11:42:30 |
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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
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
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
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
168
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
Completed
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 | 10 | 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
| 2024 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044300
