![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000047665 |
Receipt No. | R000054348 |
Scientific Title | Assessment of the Effectiveness of HER2 Vaccine Therapy |
Date of disclosure of the study information | 2022/05/06 |
Last modified on | 2022/05/09 |
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 |
|
Condition | ||||||||||||||||
Condition | Esophageal Cancer, Gastric Cancer, Breast Cancer, Colorectal Cancer, Bladder Cancer, Biliary Tract Cancer | |||||||||||||||
Classification by specialty |
|
|||||||||||||||
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
Organization | International Cancer Laboratory Co., Ltd. | ||||||
Division name | Division of Research Initiatives 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 |
|
||||||
Organization | International Cancer Laboratory Co., Ltd. | ||||||
Division name | Division of Research Initiatives 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 | |
Institute | International Cancer Laboratory Co., Ltd. |
Institute | |
Department |
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) |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054348 |
Research Plan | |
Registered date | File name |
2022/05/09 | 研究計画書 第5版(2022年4月27日修正).pdf |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |