UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057049 |
|---|---|
| Receipt number | R000065201 |
| Scientific Title | Analysis of Factors Associated with the Efficacy and Safety of Tremelimumab/Durvalumab Treatment for Unresectable Hepatocellular Carcinoma |
| Date of disclosure of the study information | 2025/02/17 |
| Last modified on | 2025/02/16 21:43:37 |
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Basic information
Public title
Analysis of Factors Associated with the Efficacy and Safety of Tremelimumab/Durvalumab Treatment for Unresectable Hepatocellular Carcinoma
Acronym
Tremelimumab/Durvalumab for uHCC
Scientific Title
Analysis of Factors Associated with the Efficacy and Safety of Tremelimumab/Durvalumab Treatment for Unresectable Hepatocellular Carcinoma
Scientific Title:Acronym
Tremelimumab/Durvalumab for uHCC
Region
| Japan |
Condition
Condition
Patients with HCC
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This multicenter prospective observational study aims to identify biomarkers predictive of overall survival (OS) in patients with advanced hepatocellular carcinoma (HCC) undergoing immune checkpoint inhibitor (ICI) therapy. The study will focus on cytokines, which have been frequently reported as potential biomarkers for ICI response, and imaging findings from EOB-MRI, a candidate biomarker for OS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
18-month survival rate
Key secondary outcomes
(2) Secondary Endpoints
Objective response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)
Disease control rate (DCR)
Safety (grade 3 or higher immune-related adverse events (irAEs), irAEs requiring PSL administration)
Early response (tumor shrinkage/enlargement rate at the time of the first imaging evaluation)
(3) Exploratory Endpoints
Efficacy (OS, PFS, ORR, DCR)
Safety (grade 3 or higher irAEs, irAEs requiring PSL administration)
Association between efficacy (or safety (irAEs)) and gut microbiota as well as its metabolic products
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 aged 18 years or older
Patients with Child-Pugh class A
Individuals who are 18 years or older at the time of enrollment
Patients with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy
Patients with advanced HCC for whom surgical resection, percutaneous local therapy, or transarterial chemoembolization (TACE) is not indicated
Individuals scheduled to receive tremelimumab/durvalumab treatment as part of standard medical care
Individuals who have received a thorough explanation of the study, fully understand it, and have provided written informed consent of their own free will
Individuals with a performance status (PS) of 0 or 1
Key exclusion criteria
Individuals with a history of gastrointestinal bleeding from gastric ulcers, esophageal varices, or gastrointestinal varices within the past 12 months. However, for patients at high risk of gastrointestinal bleeding, standard medical care, including pre-treatment upper gastrointestinal examination, is recommended.
Individuals with uncontrolled cardiac disease.
Individuals with severe hepatic impairment (decompensated liver cirrhosis).
Pregnant women, women with a potential for pregnancy, or breastfeeding women.
Individuals using medications that are contraindicated according to the package insert.
Individuals with a history of prior use of immune checkpoint inhibitors (ICIs), including tremelimumab and durvalumab.
Individuals deemed unsuitable for participation in this study by the attending physician.
Any other individuals deemed inappropriate as study subjects by the principal investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | GOKI |
| Middle name | |
| Last name | SUDA |
Organization
Graduate School of Medicine, Hokkaido University
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL
011-716-2111
gsudgast@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | SUDA |
| Middle name | |
| Last name | GOKI |
Organization
Graduate School of Medicine, Hokkaido University
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL
011-716-2111
Homepage URL
gsudgast@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14-jo Nishi 5-chome, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurement Items
Blood tests
Serum cytokines and chemokines*
Genetic mutations in cell-free DNA from blood
Gut microbiota and metabolome analysis in stool samples
Management information
Registered date
| 2025 | Year | 02 | Month | 16 | Day |
Last modified on
| 2025 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065201
