UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011177 |
|---|---|
| Receipt number | R000013093 |
| Scientific Title | The efficacy and safety of combination therapy of adoptive immunotherapy with chemotherapy for advanced pancreatic cancer |
| Date of disclosure of the study information | 2013/07/11 |
| Last modified on | 2018/01/14 17:10:29 |
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Basic information
Public title
The efficacy and safety of combination therapy of adoptive immunotherapy with chemotherapy for advanced pancreatic cancer
Acronym
Combination therapy of immunotherapy with chemotherapy for pancreatic cancer
Scientific Title
The efficacy and safety of combination therapy of adoptive immunotherapy with chemotherapy for advanced pancreatic cancer
Scientific Title:Acronym
Combination therapy of immunotherapy with chemotherapy for pancreatic cancer
Region
| Japan |
Condition
Condition
unresectable advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of combination therapy of adoptive immunotherapy with chemotherapy for unresectable advanced pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival (OS)
Key secondary outcomes
Survival rate (one year), Progression free survival, Quality of life (QOL), Tumor marker, Immunorogic reaction, The kind and frequency of side effect
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Pancreatic cancer diagnosed histologically
2. Age: more than 20 years old and 20 y
3. Patients treated with chemottherapy
4. Performance status: 0-2
5. Survival more than three months
6. Maintained bone marrow, liver function and renal function
7. Written informed consent
Key exclusion criteria
1. Interstitial pneumonia
2. Active autoimmune disease
3. Uncontroled infection
4. Severe drug allergy
5. Continued steroid therapy
6. Pregnancy
7. HIV or HTLV-1 positive
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kawaguchi |
Organization
Tokai University School of Medicine
Division name
Gastroenterology
Zip code
Address
143, Shimokasuya, Isehara
TEL
0463-93-1121
y711kawa@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kawaguchi |
Organization
Tokai University School of Medicine
Division name
Gastroenterology
Zip code
Address
143, Shimokasuya, Isehara
TEL
0463-93-1121
Homepage URL
y711kawa@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seta clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 07 | Month | 11 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate the efficacy and safety of immunotherapy combined with chemotherapy for unresectable advanced pancreatic cancer.
Management information
Registered date
| 2013 | Year | 07 | Month | 11 | Day |
Last modified on
| 2018 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013093
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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