Status:
UNKNOWN
Efficacy Study of TKcell in Advanced Gastric Cancer
Lead Sponsor:
Binex
Conditions:
Advanced Gastric Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine efficacy of NKCell combined FOLFOX-4 chemotherapy in gastric cancer
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00854854
Start Date
January 1 2009
End Date
July 1 2010
Last Update
May 18 2009
Active Locations (1)
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1
The catholic University of korea
Banpo-dong, Seoul, South Korea, 137-701