Evaluating the Safety and Efficacy of Combination Therapy With FOLFOX-4 and TKcell Therapy Versus FOLFOX-4 Alone in Patients With Recurrent, Unresectable and Advanced Gastric Cancer
Inclusion Criteria:
- Written informed consent.
- Diagnosis of histologically confirmed adenocarcinoma of the gastric
- ECOG performance status of 0 - 2
- At least one definite measurable lesion(s): ≥ 1 cm on spiral CT scan or ≥2cm in
physical examination
- Adequate liver, renal, bone marrow functions as evidence by the following; Absolute
neutrophil count > 1.5 x 109/L; platelets > 7.5 x 109/L; Bilirubin less than 2 mg/dL
ASAT and/or ALAT < 5 UNL; serum creatinine ≤ 2 ULN
- Minimum life expectancy of 12 weeks
- Effective contraception for both male and female subjects if the risk of conception
exists
Exclusion Criteria:
- Brain metastasis and/or leptomeningeal disease (known or suspected)
- Previous chemotherapy for gastric cancer except adjuvant treatment with progression
of disease documented > 6 months after end of adjuvant treatment.
- Previous oxaliplatin-based chemotherapy
- Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to
randomization and chemotherapy
- HIV antibody (+), Chronic hepatitis
- Uncontrolled infection
- Concurrent or previous chronic systemic immune therapy, targeted therapy, hormonal
therapy not indicated in the study protocol except for contraception
- Clinically relevant coronary artery disease, history of myocardial infarction, high
risk of uncontrolled arrhythmia
- Known hypersensitivity reaction to any of the components of the treatment.
- Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
- Participation in another clinical study within the 30 days before randomization
- Significant disease which, in the investigator's opinion, would exclude the subject
from the study