UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015887 |
|---|---|
| Receipt number | R000018491 |
| Scientific Title | Salvage TACE for unresectable HCC: switching the chemotherapeutic agents. |
| Date of disclosure of the study information | 2014/12/09 |
| Last modified on | 2023/12/19 10:11:11 |
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Basic information
Public title
Salvage TACE for unresectable HCC: switching the chemotherapeutic agents.
Acronym
Switching chemotherapeutic agents in TACE
Scientific Title
Salvage TACE for unresectable HCC: switching the chemotherapeutic agents.
Scientific Title:Acronym
Switching chemotherapeutic agents in TACE
Region
| Japan |
Condition
Condition
Unresectable hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of switching the anticancer agents in TACE
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy and safety of second-line TACE
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment regimens
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
1) HCC is diagnosed on the basis of positive results in pathology and/or radiologic imagings
2) Patients are not eligible for surgical resection or percutaneous ablation
3) Efficacy after the first-line TACE using epirubicin-lipiodol is progressive disease.
Key exclusion criteria
1)HCC with macrovascular invasion and/or extrahepatic metastasis
2)Child-Pugh score =/> 10
3)Patients who cannot be performed TACE technically
4)Patients received previous cisplatin-based chemotherapy
5)Patients received previous systemic chemotherapy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Morimoto |
Organization
Kanagawa Cancer Center
Division name
Hepatobiliary and Pancreatic Oncology
Zip code
Address
2-3-2 Nakao, Asahi-ku, Yokohama
TEL
+81-45-520-2222
m-morimoto@kcch.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Goda |
Organization
Kanagawa Cancer Center
Division name
Hepatobiliary and Pancreatic Oncology
Zip code
Address
2-3-2 Nakao, Asahi-ku, Yokohama
TEL
+81-45-520-2222
Homepage URL
y-gouda@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa research funding
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 12 | Month | 09 | 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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018491
