UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012201 |
|---|---|
| Receipt number | R000014253 |
| Scientific Title | Clinical study of combination therapy of adoptive immunotherapy with proton therapy for pancreatic cancer |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2025/01/10 13:10:52 |
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Basic information
Public title
Clinical study of combination therapy of adoptive immunotherapy with proton therapy for pancreatic cancer
Acronym
Clinical study of combination therapy of adoptive immunotherapy with proton therapy for pancreatic cancer
Scientific Title
Clinical study of combination therapy of adoptive immunotherapy with proton therapy for pancreatic cancer
Scientific Title:Acronym
Clinical study of combination therapy of adoptive immunotherapy with proton therapy for pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy about immunotherapy after proton therapy of pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
distant disease-free rate
Key secondary outcomes
overall survival
survival rate
local control rate
frequency and type of adverse events
QOL
immunological parameters
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 | Maneuver |
Interventions/Control_1
Proton therapy
Alpha-Beta T-cell Therapy
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
(1)Locally advanced pancreatic cancer eligible for the inclusion criteria and ineligible for the exclusion criteria of Hyogo Ion Beam Medical Center
(2)Patients who can initiate immunotherapy within three months after proton therapy
(3)over 20 years old
(4)Performance Status is 0-2
(5)Survival more than three months
(6)No serious abnormality in bone marrow, liver, and renal functions
(7)Informed consent has been obtained
Key exclusion criteria
(1)Interstitial pneumonia
(2)Active autoimmune disease
(3)Active heart trouble
(4)uncontrolable infectious diseases.
(5)Serious drug allergy
(6)Continuous systemic administration of steroids
(7)Pregnancy
(8)Positive for HIV or HTLV-1
(9)patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Terashima |
Organization
Hyogo Ion Beam Medical Center
Division name
Department of Radiology
Zip code
679-5165
Address
1-2-1, Kouto, Tatsuno city, Hyogo, 679-5165, Japan
TEL
0791-58-0100
k.terashima@hibmc.shingu.hyogo.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Terashima |
Organization
Hyogo Ion Beam Medical Center
Division name
Department of Radiology
Zip code
679-5165
Address
1-2-1, Kouto, Tatsuno city, Hyogo, 679-5165, Japan
TEL
0791-58-0100
Homepage URL
k.terashima@hibmc.shingu.hyogo.jp
Sponsor or person
Institute
Hyogo Ion Beam Medical Center
Institute
Department
Personal name
Funding Source
Organization
Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seta Clinic Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seta Clinic Group Certified Committee for Regenerative Medicine
Address
3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 101-0062 JAPAN
Tel
03-5244-5751
ccrm@j-immunother.com
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
兵庫県立粒子線医療センター（兵庫県）
瀬田クリニックグループ（東京、新横浜、大阪、福岡）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | 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
14
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
| 2013 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 01 | Day |
Last modified on
| 2025 | 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=R000014253
