UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047665 |
|---|---|
| Receipt number | R000054348 |
| Scientific Title | Assessment of the Effectiveness of HER2 Vaccine Therapy |
| Date of disclosure of the study information | 2022/05/06 |
| Last modified on | 2023/02/22 17:26:12 |
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Basic information
Public title
Molecular Targeted Vaccine Therapy for Cancer
Acronym
Molecular Targeted Vaccine Therapy for Cancer
Scientific Title
Assessment of the Effectiveness of HER2 Vaccine Therapy
Scientific Title:Acronym
HER2 Vaccine Therapy
Region
| Japan |
Condition
Condition
Esophageal Cancer, Gastric Cancer, Breast Cancer, Colorectal Cancer, Bladder Cancer, Biliary Tract Cancer
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Endocrinology and Metabolism | Hematology and clinical oncology | Surgery in general |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Urology |
| Laboratory medicine | Operative medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assess the efficacy of HER2 vaccine therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum HER2 concentration
Tumor marker concentrations
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
Injection of HER2 vaccine
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. Must have histologically confirmed solid tumor
2. Women must not be pregnant
3. Doesn't have heart disease
4. Ability to understand and the willingness to sign a written informed consent document; the patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
Key exclusion criteria
1. Patients with intracranial bleeding
2. Patients who have evidence of active infection that requires antibiotic therapy; patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment
3. Patients with known active human immunodeficiency virus (HIV), hepatitis A, hepatitis B, or hepatitis C infection
4. Patients with serious cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases
5. Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible
6. Splenectomized patients
7. Autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermatomyositis, or a vasculitic syndrome
8. Patients who have developed anaphylactic responses to other vaccines
9. History of congestive heart failure, coronary artery disease and myocardial infarction; active or unstable cardiovascular disease or cardiac disease requiring drug or device intervention
10. Patients on HER2 targeted therapies, such as Herceptin, Perjeta, Kadcyla, and Enhertu.
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Ubuka |
Organization
International Cancer Laboratory Co., Ltd.
Division name
Division of Initiatives for Research and Development
Zip code
104-0014
Address
2nd Floor, No. 3 Toho Bldg. 1-6-8 Shintomi, Chuo-ku, Tokyo
TEL
03-6426-0316
t.ubuka@ic-lab.jp
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Ubuka |
Organization
International Cancer Laboratory Co., Ltd.
Division name
Division of Initiatives for Research and Development
Zip code
104-0014
Address
2nd Floor, No. 3 Toho Bldg. 1-6-8 Shintomi, Chuo-ku, Tokyo
TEL
03-6426-0316
Homepage URL
t.ubuka@ic-lab.jp
Sponsor or person
Institute
International Cancer Laboratory Co., Ltd.
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
Nihonbashi Sakura Clinic IRB
Address
5th Floor Inamura Bldg. 1-9-2 Kayabacho Nihonbashi Chuo-ku, Tokyo
Tel
03-6661-9061
c-irb_ug@neues.co.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
名古屋がん中央クリニック（愛知県）
医療法人知慎会 JTKクリニック（東京都）
医療法人順生会 芦屋グランデクリニック（兵庫県）
医療法人仁善会 田中クリニック（大阪府）
医療法人医新会 よろずクリニック（鳥取県）
サンクリニック ブレストケア・イムノケア（東京都）
東京CRクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 05 | Month | 06 | Day |
Last modified on
| 2023 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054348
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/02/22 | 研究計画書 第14版（2023年2月9日修正）.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
