Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAV-DC-CTL | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene | Biological | AAV-DC-CTL: Intravenous infusion, 1×109 cells, day 14; one cycle every month; at least one cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | CR + PR = ORR | Up to 12 months |
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided