Advanced Colorectal Cancer
Conditions
Keywords
NKCell, FOLFOX-4, advanced or unresectable colorectal cancer
Brief summary
The purpose of this study is to determine efficacy of NKCell in colorectal cancer
Interventions
BIOLOGICALTKCell
Biological/Vaccine: TKCell
Sponsors
Binex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
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