UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034537 |
|---|---|
| Receipt number | R000039088 |
| Scientific Title | Evaluation of safety and efficacy of colon cancer stem cell target immunotherapy |
| Date of disclosure of the study information | 2018/10/17 |
| Last modified on | 2019/03/31 11:11:53 |
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Basic information
Public title
Evaluation of safety and efficacy of colon cancer stem cell target immunotherapy
Acronym
Evaluation of safety and efficacy of colon cancer stem cell target immunotherapy
Scientific Title
Evaluation of safety and efficacy of colon cancer stem cell target immunotherapy
Scientific Title:Acronym
Evaluation of safety and efficacy of colon cancer stem cell target immunotherapy
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We are conducting an exploratory Phase 1/2 clinical study to examine the safety and efficacy of combined immunotherapy that activates immune activity targeted to cancer stem cells in advanced colorectal cancer refractory to chemotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
1) Safety
2) Immunological response
Key secondary outcomes
1) Disease Control Rate
2) Progression-Free Survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
OR7C1+IFNb
Interventions/Control_2
BORIS+IFNb
Interventions/Control_3
OR7C1+IFNa
Interventions/Control_4
BORIS+IFNa
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients with a definitive diagnosis of colorectal adenocarcinoma.
(2) Patients with expression of HLA class I in cancer cells.
(3) Patients must meet all of the following criteria.
Patients diagnosed as being impossible to remove lesions by surgery, patients who meet one of the following criteria.
a) Patients who have already completed 2nd-line chemotherapy and have ceased due to refractory anticancer drugs or side effects.
b) Patient who refused chemotherapy.
(4) Patients with measurable lesion as determined by CT or MRI at screening period.
(5) Patients with HLA-A24 or HLA-A2 positive.
(6) Patients with ECOG Performance Status 0 or 1.
(7) Patients without serious organ failure within 30 days prior to registration (neutrophil >=1,500/uL, hemoglobin level >=8.0 g/dL, platelet count >=75,000/uL, 1.5 times serum creatinine level <= normal upper limit level, 3 times total serum bilirubin level <= normal upper limit level, AST and ALT <=3 times normal upper limit level).
(8) Patients aged 20-85 years when providing informed consent.
(9) Patients who have received sufficient explanation of this trial.
Key exclusion criteria
(1) HIV positive.
(2) Heart disease under NYHA III or IV classification.
(3) Uncontrollablediabetes/hypertension.
(4) Pleural effusion/pericardial fluid/ascites).
(5) Autoimmune disease.
(6) History of interstitial pneumonia.
(7) Organ transplantation (including hematopoietic stem cell transplantation)
(8) Life-threatening diseases.
(9) History of immune cell therapy for cancer.
(10) Received followingtreatmentdesignated period prior to registration.
a)Surgery/radiotherapy.
b)Chemotherapy.
c)Endocrine therapy/immunotherapy.
d)Blood transfusion/hematopoietic factor.
e)Application of immunosuppressive drug.
f)Investigational/unlicensed drugs.
(11) Use of Sho-sai-koto/warfarin/ theophylline.
(12) Steroids use required.
(13) History of severe drug allergy.
(14) Sensitive to cow materials.
(15) Sensitive to biological preparation.
(16) Severe psychosis/neurologic manifestation.
(17) Pregnant/lactating. Hope to conceive during trial/unable to use contraception.
(18) Disqualified for trial by principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takemasa |
Organization
Sapporo medical university hospital
Division name
Department of Surgery,Surgical Oncology and Science
Zip code
0608556
Address
nishi 16 choume minami 1 jyo Chuo-ku Sapporo
TEL
011-611-2111
okuya@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Torigoe |
Organization
Sapporo medical university
Division name
Department of Pathology(I)
Zip code
0608556
Address
nishi 17 choume minami 1 jyo Chuo-ku Sapporo
TEL
011-611-2111
Homepage URL
torigoe@sapmed.ac.jp
Sponsor or person
Institute
Sapporo medical university
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and
Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo medical university hospital
Address
nishi 16 choume minami 1 jyo Chuo-ku Sapporo
Tel
011-611-2111
ji-rskk@sapmed.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
| 2018 | Year | 10 | Month | 17 | 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
| 2018 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2018 | Year | 10 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039088
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| Registered date | File name |
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