UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058215 |
|---|---|
| Receipt number | R000066546 |
| Scientific Title | Association between early response and clinical outcomes of Nivolumab + Ipilimumab combination therapy for advanced hepatocellular carcinoma: A multicenter prospective observational study |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/18 23:43:46 |
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Basic information
Public title
Association between early response and clinical outcomes of Nivolumab + Ipilimumab combination therapy for advanced hepatocellular carcinoma: A multicenter prospective observational study
Acronym
Early response of Nivolumab + Ipilimumab combination therapy for advanced hepatocellular carcinoma
Scientific Title
Association between early response and clinical outcomes of Nivolumab + Ipilimumab combination therapy for advanced hepatocellular carcinoma: A multicenter prospective observational study
Scientific Title:Acronym
Association between early response and clinical outcomes of Nivolumab + Ipilimumab combination therapy for advanced hepatocellular carcinoma: A multicenter prospective observational study
Region
| Japan |
Condition
Condition
Unresectable hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This multicenter, prospective, observational study will enroll patients receiving nivolumab + ipilimumab combination therapy, and assess the association
between early response and treatment outcome. The aim of the study is to clarify the appropriate dosing and management indicators for this combination therapy and to contribute to the development of safe and effective treatment strategies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between antitumor response by RECIST at 4 weeks after treatment and time to progression (TTP)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who provided written informed consent after receiving adequate explanation and demonstrating sufficient understanding, based on their own free will, to participate in this study
2. Patients aged 20 years or older at the time of consent acquisition
3. Patients with unresectable hepatocellular carcinoma
4. Patients with at least one measurable lesion (RECIST v1.1)
5. Patients with Child-Pugh classification A or B
6. Patients with an ECOG performance status (PS) of 2 or lower
Key exclusion criteria
1. Patients receiving combination therapy with other anticancer agents
2. Patients with a history of systemic chemotherapy (using cytotoxic anticancer agents)
3. Patients with active concurrent cancer
4. Patients for whom administration of this drug is not recommended
Patients with a history of severe hypersensitivity to any component of this drug
Pregnant women or women who may become pregnant
Patients with brain tumors
Patients undergoing dialysis
Patients with uncontrolled hypertension
Patients who have been diagnosed with any of the following conditions within 12 months prior to registration
Myocardial infarction, unstable angina, heart failure, cerebrovascular disorder
Patients with esophageal varices at risk of bleeding
Patients currently receiving CYP3A4 inducers (e.g., rifampicin)
5. Other patients deemed inappropriate by the principal investigator or sub-investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Teiji |
| Middle name | |
| Last name | Kuzuya |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Hepatology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake- Cho, Toyoake, Aichi
TEL
0562932324
teiji.kuzuya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Teiji |
| Middle name | |
| Last name | Kuzuya |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Hepatology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake- Cho, Toyoake, Aichi
TEL
0562932324
Homepage URL
teiji.kuzuya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
None
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
Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake- Cho, Toyoake, Aichi
Tel
+81562932865
f-irb@fujita-hu.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 | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 06 | Month | 18 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066546
