UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053532 |
|---|---|
| Receipt number | R000061093 |
| Scientific Title | A multicenter observational study on the efficacy and safety of systemic therapy for hepatocellular carcinoma |
| Date of disclosure of the study information | 2024/02/03 |
| Last modified on | 2024/02/03 23:31:13 |
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Basic information
Public title
A multicenter observational study on the efficacy and safety of systemic therapy for hepatocellular carcinoma
Acronym
A multicenter observational study on systemic therapy for liver cancer
Scientific Title
A multicenter observational study on the efficacy and safety of systemic therapy for hepatocellular carcinoma
Scientific Title:Acronym
A multicenter observational study on the efficacy and safety of systemic therapy for hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this research is to identify useful indicators for predicting the therapeutic effects of each regimen used in the systemic therapy for hepatocellular carcinoma.
The secondary aim is to investigate the safety and treatment efficacy of each regimen in patients not targeted in previous clinical trials.
This research is expected to enable more appropriate drug selection for patients with hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Overall survival
Best overall response
Objective response rate
Disease control rate
Proportion of patients undergoing curative conversion therapy
Treatment-related adverse events
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients administered with either sorafenib, lenvatinib, atezolizumab plus bevacizumab, regorafenib, ramucirumab or cabozantinib for hepatocellular carcinoma at the participating institutions between May 2009 and September 2022
Key exclusion criteria
Patient without adequate baseline information due to reasons such as an initiation of treatment at another institution
Patients without adequate follow-up period for reasons such as transferring to another hospital before radiological assessment of treatment response
Patients considered inappropriate as subjects for this study by the principal investigator or researchers involved in the study
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Takai |
Organization
Kyoto University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3111
atsushit@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ueno |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3111
Homepage URL
masayukiu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Atsushi Takai
Funding Source
Organization
Department of Gastroenterology and Hepatology, Kyoto University Hospital
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 University Graduate School and Fac ulty of Medicine, Ethics Committee
Address
Yoshidakonoecho, Sakyo-ku, Kyoto 606-8315 Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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
京都大学医学部附属病院（京都府）
尼崎総合医療センター（兵庫県）
大阪赤十字病院（大阪府）
京都医療センター（京都府）
京都桂病院（京都府）
倉敷中央病院（岡山県）
滋賀県立総合病院（滋賀県）
日赤和歌山医療センター（和歌山県）
明和病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 03 | 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
| 2023 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For previously reported predictive markers, patients will be stratified using the reported cut-off values and the reproducibility of their association with progression-free survival and overall survival will be assessed.
For markers without previous reports, an exploratory investigation will be conducted, such as comparing the patient baseline characteristics of responders and non-responders, to explore their potential significance.
Management information
Registered date
| 2024 | Year | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061093
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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