UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029412 |
|---|---|
| Receipt number | R000033614 |
| Scientific Title | Safety study of adjuvant therapy using alpha fetoprotein derived peptide after transarterial chemoembolization for hepatocellular carcinoma |
| Date of disclosure of the study information | 2017/10/04 |
| Last modified on | 2019/06/22 16:07:28 |
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Basic information
Public title
Safety study of adjuvant therapy using alpha fetoprotein derived peptide after transarterial chemoembolization for hepatocellular carcinoma
Acronym
TACE AFP peptide
Scientific Title
Safety study of adjuvant therapy using alpha fetoprotein derived peptide after transarterial chemoembolization for hepatocellular carcinoma
Scientific Title:Acronym
TACE AFP peptide
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety study of AFP derived peptide after transarterial chemoembolization for hepatocellular carcinoma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severe adverse events
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
AFP derived peptides
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) Clinically diagnosed as hepatocellular carcinoma
2) Conducted transarterial chemoembolization
3) Complete response to transarterial chemoembolization
4) Recovery from adverse events for transarterial chemoembolization
5) HLA A24
6) Child Pugh classification A or B
7) 20 years or older
8) ECOG Performance status 0, 1 or 2
9) Reserved major organ function
Neutrophil 1,000/mm3 or more; Hemoglobin 8.0 g/dl or more; Platelet 40,000 /mm3 or more; Total bilirubin 3.0 mg/dl or less
10) Written informed consent
Key exclusion criteria
1) Refractory ascites or pleural effusion
2) History of hepatic encephalopathy within 3 months
3) Risky varices
4) Active double cancer
5) Transfusion of RCC, PC, FFP, or G-CSF within 2 weeks
6) Administration of steroid or immuno suppressive agents
7) Severe complication
8) Systemic infection (excluded viral hepatitis)
9) Pregnant or lactating women, or women of childbearing potential
10) Mental disorder
11) Allergy for AFP derived peptides or adjuvant
12) Allergy for contrast agent of CT or/and MRI
13) Inappropriate candidate for this study judged by doctor in charge
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eishiro Mizukoshi |
Organization
Kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
Address
13-1, Takaramachi, Kanazawa
TEL
076-265-2235
eishirom@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Terashima |
Organization
Kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
Address
13-1, Takaramachi, Kanazawa
TEL
076-265-2235
Homepage URL
tera@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Hospital
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
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
| 2017 | Year | 10 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 04 | Day |
Last modified on
| 2019 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033614
