UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043639
Receipt No. 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 2021/03/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tahkun56@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

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
Email 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
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
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
Date analysis concluded

Other
Other related information None

Management information
Registered date
2021 Year 03 Month 17 Day
Last modified on
2021 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049837

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.