UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013709 |
|---|---|
| Receipt number | R000016004 |
| Scientific Title | Treatment with cancer peptide vaccine cocktail derived from URLC10, KIF20A, VEGFR-1 and VEGFR-2 for the patients with advanced or recurrent esophageal cancer refractory to the standerd tharapy |
| Date of disclosure of the study information | 2014/04/15 |
| Last modified on | 2020/01/23 20:47:03 |
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Basic information
Public title
Treatment with cancer peptide vaccine cocktail derived from URLC10, KIF20A, VEGFR-1 and VEGFR-2 for the patients with advanced or recurrent esophageal cancer refractory to the standerd tharapy
Acronym
Treatment with cancer peptide vaccine cocktail for the patients with advanced or recurrent esophageal cancer refractory to the standerd tharapy
Scientific Title
Treatment with cancer peptide vaccine cocktail derived from URLC10, KIF20A, VEGFR-1 and VEGFR-2 for the patients with advanced or recurrent esophageal cancer refractory to the standerd tharapy
Scientific Title:Acronym
Treatment with cancer peptide vaccine cocktail for the patients with advanced or recurrent esophageal cancer refractory to the standerd tharapy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Tp evaluate the safety and efficacy of peptide vaccine cocktail therapy in esophageal cancer refractory or intolerable to standard therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety: Adverse event
Efficacy: Overall survival
Key secondary outcomes
immunological evaluation
Progression free survival
Response rate (RECISTv1.1, irRC)
QOL
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
peptides derived from URLC10, KIF20A, VEGFR-1 and VEGFR-2
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
Patients must have histologically or cytologically confirmed adenocarcinoma, adenosquamous carcinoma or squamous carcinoma of the esophagus.
Patients must be diagnosed to be refractory or intolerable to standerd anti-cancer drugs such as fluoropyrimidine, platinum and Taxane.
KPS of 80 to 100.
Patients must be HLA-A02 or HLA-A24.
Life expectancy at least 3 months.
Age >= 20 years.
Patients must have normal organ and marrow function as defined below:
white blood cells; >=2000,<=15000
platelets; >= 50000
total bilirubin; <=3.0mg/dL
AST; <=150IU/L
ALT; <=150IU/L
Creatinine; <=2.0mg/dL
The willingness to sign a written informed consent document.
Key exclusion criteria
Patients who received all peptides derived from VEGFR-1, VEGFR-2, URLC10 and KIF20A.
Patients with other malignant tumor except for mucosal lesion.
Primary tumor is widely invaded to other organs and is strongly concerned to bleed.
History or intercurrent illness of intestinal pneumonia or pulmonary fibrosis.
Symptomatic CNS metastasis.
Patients with pleural effusion, abdominal effusion or pericardial effusion requiring a puncture or drainage.
Severe infection or suspicious of severe infection.
Severe mental disorder or severe neurological disorder.
Uncontrolled heart, lung, kidney, or liver disease.
Other uncontrolled intercurrent illness.
Previous history of myocardial infarction, severe unstable angina, CABG surgery, congestive heart failure, cerebrovascular disease, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism within 12 months prior to drug administration.
Uncured traumatic injury (including traumatic bone fracture).
Bleeding diathesis (including the fatal aneurysm) or coagulopathy.
Continuous administration of antithrombotic drugs except for aspirin.
Treatment-resistant hypertension.
Heart failure under treatment.
Patients receiving other investigational agents.
Women who are breast-feeding or pregnant. Patients without intention to contraception.
Patients who are judged as ineligible to attend study by investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yamaue |
Organization
Wakayama medical university
Division name
2nd. department of Surgery
Zip code
6418510
Address
811-1 Kimiidera Wakayama-city, Wakayama
TEL
073-441-0613
yamaue-h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Katsuda |
Organization
Wakayama medical university
Division name
2nd. department of Surgery
Zip code
6418510
Address
811-1 Kimiidera Wakayama-city, Wakayama
TEL
073-441-0613
Homepage URL
katsuda@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
2nd dept of Surg, Wakayama medical Univ.
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
Wakayama Medical University Ethics Review Committee
Address
811-1 Kimiidera Wakayama-city, Wakayama
Tel
074-447-2300
wa-rinri@wakayama-med.ac.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
和歌山県立医科大学（和歌山県）、北海道がんセンター（北海道）、東北大学（宮城県）、千葉大学（千葉県）、東海大学（静岡県）、岐阜大学（岐阜県）、川崎医科大学（岡山県）、鹿児島大学（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 15 | 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 | 06 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | 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 | 04 | Month | 14 | Day |
Last modified on
| 2020 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016004
