UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043219 |
|---|---|
| Receipt number | R000049324 |
| Scientific Title | Systemic therapy against unresectable hepatocellular carcinoma |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2024/02/04 09:22:03 |
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Basic information
Public title
Systemic therapy against unresectable hepatocellular carcinoma
Acronym
Systemic therapy against unresectable hepatocellular carcinoma
Scientific Title
Systemic therapy against unresectable hepatocellular carcinoma
Scientific Title:Acronym
Systemic therapy against u-HCC
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation for improving overall survival by systemic therapy in patients with unresectable HCC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival after introducing initial systemic treatment
Key secondary outcomes
Anti-tumor responses of systemic treatments (RECIT/ mRECIST), Progression free survival and time to progression of each systemic treatment, adverse events of each systemic treatment, relative changes of hepatic reserve function, nutritional status, tumor markers, physical conditions (muscle volume, muscle strength, body weight), adverse event
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with unresectable liver cancer who received systemic drug treatment
Key exclusion criteria
Patients who disagree with data use
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Hiraoka |
Organization
Ehime Prefectural Central Hospital
Division name
Gastroenterology Center
Zip code
7900011
Address
83 Kasuga-cho, Matsuyama, Ehime, Japan
TEL
81899471111
hirage@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Hiraoka |
Organization
Ehime Prefectural Central Hospital
Division name
Gastroenterology Center
Zip code
7900011
Address
83 Kasuga-cho, Matsuyama, Ehime, Japan
TEL
81899471111
Homepage URL
hirage@m.ehime-u.ac.jp
Sponsor or person
Institute
RELPEC and HCC48
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
Ehime Prefectural Central Hospital
Address
83 Kasuga-cho, Matsuyama, Ehime, Japan
Tel
81899471111
hirage@m.ehime-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 | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.eph.pref.ehime.jp/epch/patient/asset/30-66.pdf
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35666040/
Number of participants that the trial has enrolled
251
Results
Following adjustment with inverse probability weighting (IPW), Atez/Bev-group showed better PFS (0.5-/1-/1.5-years: 56.6%/31.6%/non-estimable vs. 48.6%/20.4%/11.2%, p < 0.0001) and OS rates (0.5-/1-/1.5-years: 89.6%/67.2%/58.1% vs. 77.8%/66.2%/52.7%, p = 0.002).
Results date posted
| 2024 | Year | 02 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
unresectable hepatocellular carcinoma patients treated with systemic chemotherapy
Participant flow
Enrollment of patients excluding those who did not consent to prospective backward-looking studies
Adverse events
none
Outcome measures
PFS, OS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2024 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049324
