Efficacy Study of TKcell in Advanced Colorectal Cancer

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 Colorectal Cancer

The purpose of this study is to determine efficacy of NKCell in colorectal cancer

Inclusion Criteria:

• Written informed consent.
• Diagnosis of histologically confirmed adenocarcinoma of the colorectal
• 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