Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer
This trial is active, not recruiting.
|Condition||stage iv gastric cancer|
|Treatment||antigen-specific cytotoxic t lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with cea gene|
|Sponsor||Tianjin Medical University Cancer Institute and Hospital|
|Start date||May 2012|
|End date||October 2016|
|Trial size||30 participants|
|Trial identifier||NCT01637805, CIH-ZRP-201205001|
The purpose of this study is to evaluate the clinical safety and preliminary efficacy of antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.
|Intervention model||single group assignment|
|Primary purpose||supportive care|
Objective response rate
time frame: Up to 12 months
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - Sex: male or female - 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 - Sex: male or female - 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: - History of neoplasms: other neoplasms - 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
|Official title||Phase 1 Study of Antigen-specific Cytotoxic T Lymphocytes Induced by Dendritic Cells Infected by Recombinant Adeno-associated Virus With CEA Gene in Stage IV Gastric Cancer|
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