UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011079 |
|---|---|
| Receipt number | R000012969 |
| Scientific Title | Combination therapy of radiation and intratumoral directo injection of dendritic cells for advanced esophageal cancer, a phase I study. |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2013/11/05 19:10:39 |
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Basic information
Public title
Combination therapy of radiation and intratumoral directo injection of dendritic cells for advanced esophageal cancer, a phase I study.
Acronym
Chiba RT-DC therapy
Scientific Title
Combination therapy of radiation and intratumoral directo injection of dendritic cells for advanced esophageal cancer, a phase I study.
Scientific Title:Acronym
Chiba RT-DC therapy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety of combination therpay of radiotherapy and direct injection of dendritic cells.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Vaccine | Device,equipment |
Interventions/Control_1
Direct intratumoral injection of dendtiric cells
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Squamous cell carcinoma
2.All standard treatments has been failured, and there shuould be at least one leasion to which dentritic cells can be diretly injected.
3.At least one measurable leasion.
4. Age: 20 and more, 74 and younger.
5.Performance Status (ECOG):0 or1
6.At least 4 weeks or more has been past since previous treatments.
7.Two or more months of survival can be expected.
8.Apparopriate organ functions are preserved.
Key exclusion criteria
1.Previous immunotehrapy, previous radiation therapy
2.Fistula
3.Obvious infection
4.Alb 3.0mg/ml or less
5.Uncontrolable pleural effusion, ascites, pericardial effusion
6.Severe heart failure
7.Respiratory or other complications
8.Psychological disorders
9.Active double cancers
10.Steroid usage
11.Hepatitis B or C. HIV, HTLV-1 positive
12.Hypersensitivity for albumin
13.Pregnant woman
14.Autoimmune diseases
16.Patients who cannot undergo apheresis.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisahiro Matsubara |
Organization
Chiba University
Division name
Department of GI-Surgery
Zip code
Address
1-8-1, Inohana, Chuoku, Chiba
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Chiba University
Division name
Department of Frontier Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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 | 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
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
| 2012 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
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
| 2013 | Year | 06 | Month | 30 | Day |
Last modified on
| 2013 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012969
