UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021545 |
|---|---|
| Receipt number | R000024842 |
| Scientific Title | Phase II study of artificial tumor-antigens (GPC3/AFP/MAGE1) pulsed dendritic cell vaccination for patients with hepatocellular carcinoma after curative resection |
| Date of disclosure of the study information | 2016/03/19 |
| Last modified on | 2017/09/22 07:24:11 |
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Basic information
Public title
Phase II study of artificial tumor-antigens (GPC3/AFP/MAGE1) pulsed dendritic cell vaccination for patients with hepatocellular carcinoma after curative resection
Acronym
Phase II study of DC immunotherapy for resected HCC
Scientific Title
Phase II study of artificial tumor-antigens (GPC3/AFP/MAGE1) pulsed dendritic cell vaccination for patients with hepatocellular carcinoma after curative resection
Scientific Title:Acronym
Phase II study of DC immunotherapy for resected HCC
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to assess the efficiency of artificial tumor-antigens (GPC3/AFP/MAGE1) pulsed dendritic cell vaccination as adjuvant therapy for HCC patients who underwent curative resection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Two-year recurrence rate
Key secondary outcomes
Recurrence free survival rate
Grade and efficient of SAE and adverse events
Induction antigen-specific immune response
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
| Vaccine |
Interventions/Control_1
Administration of DC vaccine 7 times, every two weeks, which quality was well controlled for three weeks culture and maturation of DCs after apheresis.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) With pathological confirmation of HCC after the surgery
2) After R(-) resection without tumor residual, and no evidence of recurrence by CT/MRI images
3) Performance status (ECOG) 0, 1, 2
4)Without participations of any other clinical research nor trials.
5)Tolerable cardiovascular disease for the aphaeresis.
6)Patients expected for completion of 7 times administration of DC vaccination
7)Adequate hematologic, hepatic, renal, and cardiac function
8)Negative with HBV, HTLV-1, HIV and so on
9)Written informed consent
Key exclusion criteria
1) Sever hemorrhagic diathesis
2) Sever psychiatric or mental disorder
3) Severe comorbidity of heart disease (NYHA classIII, IV)
4) Past history of autoimmune disease (PSS, Sjogren syndrome, ITP, MS, RA etc.)
5) During treatment with immunosuppressive agents
6)Suspicious of immunodeficiency or opportunistic infection
7)Severe allergy with penicillin or picibanil
8) Pantients with adverse events of CTCAE v4.0 >= grade 3 of nonhematological toxicity, or >= grade 4 of hematological toxicity
9) Pregnancy, nursing women
10) Male hope to impregnate
11) Patients whom doctors judged inadequate to the enrollment of this study by other reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Suzuki |
Organization
Kitasato Institute Hospital
Division name
Surgery
Zip code
Address
5-9-1, Shirogane, Minato-ku, Tokyo, Japan
TEL
03-3444-6161
k1suzuki@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Takeuchi |
Organization
Kitasato Institute Hospital
Division name
Biomedical laboratory
Zip code
Address
5-9-1, Shirogane, Minato-ku, Tokyo, Japan
TEL
03-3444-6161
Homepage URL
take-osa@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato Institute Hospital, Kitasato University
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
None
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
北里研究所病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 19 | 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
| 2016 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 19 | Day |
Last modified on
| 2017 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024842
