UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043639 |
|---|---|
| Receipt number | R000049837 |
| Scientific Title | Study on therapeutic effect and safety for combination of immune checkpoint inhibitor and molecular-targeted therapies for unresectable hepatocellular carcinoma |
| Date of disclosure of the study information | 2021/03/17 |
| Last modified on | 2024/09/18 09:09:15 |
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Basic information
Public title
Study on effect and safety for combination of immune checkpoint inhibitor and molecular-targeted therapies for liver cancer
Acronym
Study on treatment effect with anti-cancer agents for liver cancer
Scientific Title
Study on therapeutic effect and safety for combination of immune checkpoint inhibitor and molecular-targeted therapies for unresectable hepatocellular carcinoma
Scientific Title:Acronym
Study on Biomarkers in treatment with anti-cancer agents for hepatocellular carcinoma
Region
| Japan |
Condition
Condition
unresectable hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the clinical course and patients' characteristics before and after treatment of patients treated with combination therapy of immune checkpoint inhibitors and molecular targeted therapies in a clinical setting. The analysis in this study includes the change of serum cytokine/chemokine, the population of immune-cells, and gut-microbiota.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigating the biomarkers on the therapeutic effects in short- and long-term periods.
Key secondary outcomes
Investigating the biomarkers on side effects.
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
Clinically diagnosed as HCC
No indication for local treatment such as liver resection, liver transplantation, or radiofrequency ablation
Having a treatable liver function
Performance status of 0-2 on ECOG
Age is 20 years or older.
Informed consent has been obtained
Key exclusion criteria
Patients who wish to be excluded from the study.
Patients who are pregnant, lactating, may become pregnant, or intend to become pregnant, or who wish to have a baby.
Patients with the following serious complications:
1.Cardiovascular abnormalities such as heart failure, angina pectoris, or arrhythmia that are difficult to control even after treatment.
2. Myocardial infarction within 6 months of onset
3. Renal failure
4. Active infectious disease except for viral hepatitis
5. Active gastrointestinal bleeding
6. Other active cancer requiring treatment
7. Hepatic encephalopathy or severe mental disorder
8. Severe drug allergy
9. Serious autoimmune disease.
Other conditions that the physician deems inappropriate for the safe conduct of this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Ishigami |
Organization
Nagoya University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan.
TEL
0527442169
masaishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Ito |
Organization
Nagoya University Hospital
Division name
Gastroenterology and Hepatology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan.
TEL
0527412169
Homepage URL
tahkun56@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ogaki Municipal Hospital
Kariya Toyota general hospital
Tosei General Hospital
Toyohashi Municipal Hospital
Fujita Health University
National Center for Global Health and Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan.
Tel
0527442423
tahkun56@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | 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
91
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 03 | Month | 17 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049837
