UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014481 |
|---|---|
| Receipt number | R000016778 |
| Scientific Title | The novel therapeutic cancer peptide vaccine therapy for patients with locally advanced or metastatic pacreatic cancer combined with Gemcitabine as the first line therapy.-Phase I/II study- |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2023/01/10 09:32:01 |
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Basic information
Public title
The novel therapeutic cancer peptide vaccine therapy for patients with locally advanced or metastatic pacreatic cancer combined with Gemcitabine as the first line therapy.-Phase I/II study-
Acronym
1408PC
Scientific Title
The novel therapeutic cancer peptide vaccine therapy for patients with locally advanced or metastatic pacreatic cancer combined with Gemcitabine as the first line therapy.-Phase I/II study-
Scientific Title:Acronym
1408PC
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The confirmation of the safety and the exploratory evaluation of the efficacy of the novel therapeutic cancer peptide vaccine for patients with locally advanced and metastatic pancreatic cancer combined with Gemcitabine as the first line therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
novel peptide cocktail vaccine 1mL will be administered by subcutaneous injection on days, 1,8,15 and 22 of each 28-day treatment cycles.
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)Locally advanced or metastatic pancreatic ductal carcinoma histologically confirmed as adenocarcinoma or squamous cell carcinoma.
2)no prior chemotherapy and radiotherapy
3)KPS score>=80
4)HLA-A*24 or HLA-A*02 must be positive
5)Life Expectancy must be >=3 months
6)Adequate organ functions
7)The written consent form
Key exclusion criteria
1)History of other active malignancy
2)Pancreatic cancer infiltrated into digestive tract with serious concern of bleeding
3)Interstitial pneumonia or pulmonary fibrosis
4)Brain metastasis or symptoms of it
5)Pleural effusion, ascites, and pericardial fluid requiring drainage
6)Active infections
7)Severe nervous disorder or mental disorder
8)Severe organ disorder, equivalent to CTCAE grade3 or greater
9)History of ischemic heart disease, cerebral infarction, or thromboembolism within 12 months
10)Evidence of bleeding diathesis or severe coagulopthy, or patients with those histories
11)Need continuous medication of anticoagulant drug except aspirin
12)Pregnant females or nursing mothers who can not stop lactation after the recruitment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yamaue |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department of Surgery
Zip code
6418510
Address
811-1 Kimiidera Wakayama
TEL
073-441-0613
yamaue-h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Motoki |
| Middle name | |
| Last name | Miyazawa |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department of Surgery
Zip code
6418510
Address
811-1 Kimiidera Wakayama
TEL
073-441-0613
Homepage URL
mo-0702@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Surgery, Wakayama Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Second Department of Surgery, Wakayama Medical University, School of Medicine
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, School of Medicine
Address
811-1 Kimiidera Wakayama
Tel
073-441-0613
mo-0702@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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 01 | 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
10
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
| 2014 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | 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
| 2014 | Year | 07 | Month | 04 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016778
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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