NCT01637805
Unknown
Phase 1
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
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country30 target enrollmentMay 2012
ConditionsStage IV Gastric Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stage IV Gastric Cancer
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Objective response rate
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Objective response rate
Time Frame: Up to 12 months
CR + PR = ORR
Study Sites (1)
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