UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059241 |
|---|---|
| Receipt number | R000067756 |
| Scientific Title | A Multicenter Prospective Registry of Systemic Therapy for Unresectable Hepatocellular Carcinoma with Linked Multi-omics Biobanking and Translational Validation |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/10/01 20:06:39 |
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Basic information
Public title
A Multicenter Prospective Registry of Systemic Therapy for Unresectable Hepatocellular Carcinoma with Linked Multi-omics Biobanking and Translational Validation
Acronym
LIORA (Liver cancer Immuno-Oncology biomarker Research Action)
Scientific Title
A Multicenter Prospective Registry of Systemic Therapy for Unresectable Hepatocellular Carcinoma with Linked Multi-omics Biobanking and Translational Validation
Scientific Title:Acronym
LIORA (Liver cancer Immuno-Oncology biomarker Research Action)
Region
| Japan |
Condition
Condition
Hepatocellular Carcinoma
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To elucidate predictors of therapeutic efficacy for each pharmacologic treatment of hepatocellular carcinoma and to identify clinically useful blood-based and histopathologic biomarkers. We will prospectively register all patients with HCC who are indicated for systemic therapy at Osaka University and collaborating institutions nationwide in a centralized database, collect clinical, hematologic, and histopathologic data obtained before and after treatment initiation, and analyze their associations with antitumor response and clinical outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall Survival (OS)
Key secondary outcomes
Factors associated with the efficacy of systemic anticancer therapy including clinical data and blood- and tissue-based biomarkers, including genomic data that qualify as personally identifiable codes ,with respect to ORR, PFS, and OS
Progression-Free Survival
Objective Response Rate
Correlation between pre-/post-treatment changes in biomarkers and treatment efficacy
Incidence and severity of adverse events, graded per CTCAE v5.0
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients aged over 20 years
2. Life expectancy of >12 weeks
3. Hepatocellular carcinoma diagnosed by histology, cytology or by imaging such as dynamic contrast enhanced CT or MRI
4. Not amenable to locoregional therapy and eligible for systemic pharmacotherapy
5. ECOG Performance Status 0 or 1
6. No contraindications to the planned agents per the approved package insertm, prescribing information
Key exclusion criteria
1. Patients from whom informed consent cannot be obtained
2. Patients deemed unsuitable for the study by the principal investigator or a subinvestigator
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Kodama |
Organization
The University of Osaka, graduate school of medicine
Division name
Department of gastroenterology and hepatology
Zip code
5650871
Address
2-2 Yamada-oka, Suita City, Osaka, Japan
TEL
0668793621
t-kodama@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Myojin |
Organization
The University of Osaka, graduate school of medicine
Division name
Department of gastroenterology and hepatology
Zip code
5650871
Address
2-2 Yamada-oka, Suita City, Osaka, Japan
TEL
0668793621
Homepage URL
myojin@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Yuta Myojin
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital Ethical Review Board (Observational Research Committee)
Address
2-2 Yamadaoka
Tel
0662108296
rinri@hp-crc.med.osaka-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
Osaka
Institutions
Institutions
札幌医科大学
北海道がんセンター
山形大学医学部附属病院
岩手医科大学附属病院
東北大学医学部附属病院
仙台徳洲会病院
福島県立医科大学病院
東京医科大学病院
がん研有明病院
兵庫医科大学病院
神戸大学医学部附属病院
鳥取大学医学部附属病院
香川大学医学部附属病院
福岡大学医学部附属病院
飯塚病院
九州大学医学附属病院
佐賀大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | 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
| 2025 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For advanced hepatocellular carcinoma (HCC), combination regimens incorporating immune checkpoint inhibitors have become widely used as standard of care. However, multiple therapeutic options, including molecularly targeted agents, are available, and it remains unclear which drugs are most effective for which patient subgroups. Although predictors of response to individual agents have been examined in small cohorts, there are currently no large-scale, prospective studies that can directly inform regimen selection. Accordingly, conducting a prospective study enrolling a large number of patients to stratify therapeutic efficacy across pharmacologic regimens is an urgent need.
This study aims to clarify predictors of treatment efficacy for each systemic therapy for HCC and to identify clinically useful blood-based and histopathologic biomarkers. We will prospectively register patients with HCC who are candidates for systemic therapy at Osaka University and collaborating institutions nationwide in a centralized database; collect clinical information, hematologic data, and histopathologic data obtained before and after treatment initiation; and analyze their associations with antitumor efficacy and clinical outcomes, including prognosis.
Management information
Registered date
| 2025 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067756
