Advanced Gastric Cancer
Conditions
Keywords
NKCell, FOLFOX-4, gastric cancer
Brief summary
The purpose of this study is to determine efficacy of NKCell combined FOLFOX-4 chemotherapy in gastric cancer
Interventions
BIOLOGICALTKCell
TKCell 150ml IV for 7times after each FOLFOX-4 regimen : From the second cycle of FOLFOX4(start Day1),TKCell is administered in Day3 and Day8.In the third cycle of FOLFOX4(Day1),TKCell is administered in Day3 and Day8.In the fourth cycle of FOLFOX4(Day1),TKCell is administered in Day8.In the fifth cycle of FOLFOX4(Day1),TKCell is administered in Day8.In the sixth cycle of FOLFOX4(Day1),TKCell is administered in Day8
Sponsors
Binex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine response rate | within study period |
Secondary
| Measure | Time frame |
|---|---|
| Determine safety of combination,time to treatment failure, overall survival time | within study period |
Countries
South Korea
Outcome results
None listed