NCT00854971UnknownPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Binex
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Determine response rate
Study Overview
Brief Summary
The purpose of this study is to determine efficacy of NKCell in colorectal cancer
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Determine response rate
Time Frame: within study period
Secondary Outcomes
- Determine safety of combination,time to treatment failure, overall survival time(within study period)
Investigators
Study Sites (2)
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