Clinical Safety and Preliminary Efficacy of MUC1-DC-CTL Treatment in Stage IV Gastric Cancer.
NCT ID: NCT02602249
Last Updated: 2017-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2017-10-31
2020-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Group A(control group)
saline infusion and follow up
No interventions assigned to this group
Experimental Group B
MUC1-gene-DC-CTL will be used against tumor cells.
MUC1-gene-DC-CTL
MUC1-gene-DC-CTL will be used against tumor cells.
Experimental Group C
MUC1-peptide-DC-CTL will be used against tumor cells.
MUC1-peptide-DC-CTL
MUC1-peptide-DC-CTL will be used against tumor cells.
Interventions
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MUC1-gene-DC-CTL
MUC1-gene-DC-CTL will be used against tumor cells.
MUC1-peptide-DC-CTL
MUC1-peptide-DC-CTL will be used against tumor cells.
Eligibility Criteria
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Inclusion Criteria
* Age: from 18 to 80 years
* Histology: gastric cancer
* Clinical stage: stage IV
* Karnofsky performance status: more than 50%
* Expected survival: more than 2 months
* Laboratory tests results 7 days before the start of treatment:
* White blood cells: more than 3.0 × 109/L
* Platelets: more than 100 × 109/L
* Neutrophils: more than 1.5 × 109/L
* Hemoglobin: more than 80g/L
* Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN)
* Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN
* Serum bilirubin: less than 1.25 × ULN
* Serum creatinine: less than 1.25 × ULN
* Pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment
* Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study
* Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent
Exclusion Criteria
* Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy
* Metastasis: clinical symptoms of brain metastasis
* Other clinical trial: the subject received other clinical trial before this study
* Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive
* Woman: pregnant or lactating women
* Compliance: poor compliance
18 Years
80 Years
ALL
No
Sponsors
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Beijing Doing Biomedical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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li gangyi, master
Role: STUDY_CHAIR
Beijing Doing Biomedical Co., Ltd.
Locations
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First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Huai'An First People'S Hospital
Huaian, Jiangsu, China
Beijing DOING Biomedical Co., Ltd
Beijing, , China
Countries
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Central Contacts
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Other Identifiers
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Doing-003
Identifier Type: -
Identifier Source: org_study_id
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