UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046507 |
|---|---|
| Receipt number | R000052704 |
| Scientific Title | Effectiveness of local ablation therapy for the treatment of Intermediate stage hepatocellular carcinoma |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2022/05/18 13:07:34 |
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Basic information
Public title
Effectiveness of local ablation therapy for the treatment of Intermediate stage hepatocellular carcinoma
Acronym
Local ablation therapy for Intermediate stage hepatocellular carcinoma
Scientific Title
Effectiveness of local ablation therapy for the treatment of Intermediate stage hepatocellular carcinoma
Scientific Title:Acronym
Local ablation therapy for Intermediate stage hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the efficacy of local ablation therapy for the treatment of Intermediate stage hepatocellular carcinoma by prospectively comparing the outcome of the patients treated with local ablation therapy and transcatheter arterial chemoembolization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence free survival
Key secondary outcomes
Local and distant recurrence rates
Treatment success rate
Changes of liver function
Adverse events
Length of admission and cost-effectiveness
Time to up-to-7 out
Time to treatment failure
Overall survival
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
1. Child Pugh A or B
2. Tumor number over 3 and up-to-7 in
3. All tumor nodules were planned to treat by local ablation therapy or transcatheter arterial chemoembolization
4. Treatment naive tumor or curatively treated over 6 months ago (include only first recurrence).
Key exclusion criteria
1. Tumor with vascular invasion or distant metastasis
2. Tumors were exceeded 3cm or 3 nodules, or vascular invasion or distant metastasis was presented at prior treatment.
3. Multiple primary cancer
4. Patients who were considered to be inappropriate for the study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | hideki |
| Middle name | |
| Last name | onishi |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city
TEL
086-235-7219
hdk0024@gmail.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Onishi |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city
TEL
086-235-7219
Homepage URL
hdk0024@gmail.com
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city
Tel
086-225-5991
mae6605@adm.okayama-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
| 2022 | Year | 01 | 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
| 2021 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
dynamic CT or MRI every 3 months, and
physical examination and blood chemistry
Management information
Registered date
| 2021 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052704
