Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer (AAV-DC-CTL)

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