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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000034537
Receipt No. 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

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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
Email 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
Email torigoe@sapmed.ac.jp

Sponsor
Institute Sapporo medical university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039088

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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