Efficacy Study of TKcell in Advanced Colorectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine efficacy of NKCell in colorectal cancer

Official Title
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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
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Advanced Colorectal Cancer

Intervention / Treatment
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* Biological: TKCell


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Oxaliplatin infusion (85mg/m2) on days 1 and 15 (every 2 weeks) 5-FU bolus + infusions (400 mg/m2) on days 1, 2, 15 and 16 LV infusions (200 mg/m2) on days 1, 2, 15 and 16 | |
| Active Comparator: Active<br>FOLFOX-4 regimen + Infusion of TKCell(autologous activated lymphocyte) over 2x10^9 cells, IV route, 7 times | Biological: TKCell<br>* Biological/Vaccine: TKCell<br>* Other names: FOLFOX-4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine response rate |  | within study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine safety of combination,time to treatment failure, overall survival time |  | within study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NKCell, FOLFOX-4, advanced or unresectable colorectal cancer