UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051797 |
|---|---|
| Receipt number | R000059111 |
| Scientific Title | Systemic therapy for Unresectable Hepatocellular Carcinoma: Therapeutic Effectiveness by Treatment Modality and Optimal Drug Use Order |
| Date of disclosure of the study information | 2023/08/02 |
| Last modified on | 2023/08/02 19:12:15 |
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Basic information
Public title
Systemic therapy for Unresectable Hepatocellular Carcinoma: Therapeutic Effectiveness by Treatment Modality and Optimal Drug Use Order
Acronym
Systemic therapy for unresectable HCC
Scientific Title
Systemic therapy for Unresectable Hepatocellular Carcinoma: Therapeutic Effectiveness by Treatment Modality and Optimal Drug Use Order
Scientific Title:Acronym
Systemic therapy for unresectable HCC
Region
| Japan |
Condition
Condition
Unresectable hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will collect data from multiple institutions to examine the course of systemic chemotherapy for unresectable hepatocellular carcinoma from a retrospective perspective: which drug is best suited for prolonging prognosis in individual patients, which order of use is most likely to enhance therapeutic efficacy and prolong prognosis, and the details of cases in which each drug can cause serious side effects and their relationship with the course of treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival since induction of systemic therapy.
Key secondary outcomes
The following data were collected for each regimen: Overall survival, Progression free survival, Time to Progression, post-progression survival, anti-tumor effect, complication frequency, changes in liver reserve and nutritional indices during systemic chemotherapy, changes in tumor markers, changes in physical examination findings, rate of progression to post-progression therapy, and the presence or absence of curative surgery or local therapy after tumor shrinkage and its effect.
Clinical data indicators related to life prognosis, treatment response, and occurrence of side effects will be used to construct a treatment selection decision index using AI.
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
Patients with unresectable HCC in which systemic chemotherapy drug administration treatment was introduced according to the indication criteria described in the drug package insert after the indication was obtained and consent for data analysis was obtained.
Key exclusion criteria
Patients who refuse to use clinical data (blood samples, imaging, pathology).
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Toshifumi |
| Middle name | |
| Last name | Tada |
Organization
Japanese Red Cross Society Himeji Hospital
Division name
Internal Medicine
Zip code
670-8540
Address
1-12-1 Shimoteno, Himeji, Hyogo
TEL
079-294-2251
tadat0627@gmail.com
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Tada |
Organization
Japanese Red Cross Society Himeji Hospital
Division name
Internal Medicine
Zip code
670-8540
Address
1-12-1 Shimoteno, Himeji, Hyogo
TEL
079-294-2251
Homepage URL
tadat0627@gmail.com
Sponsor or person
Institute
Japanese Red Cross Society Himeji Hospital
Institute
Department
Personal name
Funding Source
Organization
Gifu Kyoritsu University
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
Institutional Review Board in Japanese Red Cross Society Himeji Hospital
Address
1-12-1 Shimoteno, Himeji, Hyogo, Japan
Tel
079-294-2251
kyuyo@himeji.jrc.or.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
| 2023 | Year | 08 | Month | 02 | 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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was a multicenter study in Japan.
Management information
Registered date
| 2023 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059111
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
