Stage IV Gastric Cancer
Conditions
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.
Interventions
BIOLOGICALAntigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene
AAV-DC-CTL: Intravenous infusion, 1×109 cells, day 14; one cycle every month; at least one cycle
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Up to 12 months | CR + PR = ORR |
Countries
China
Outcome results
None listed