Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Cytokine induced killer cells combined chemotherapy is more effective in the treatment of advanced Pancreatic Cancer.

Detailed Description
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Pancreatic cancer is a devastating malignant disease with a median survival of 3-6 months and a 5-year survival rate of less than 5%. It is necessary to explore more treatment mode to pancreatic cancer especially advanced stage patients. This study is a prospective, randomized, open, single center phase II study. The investigators try to evaluate the efficacy and safety of this treatment mode.

Official Title
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Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer: A Prospective, Randomized, Open, Single Center Phase II Study

Conditions
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Advanced Cancer

Intervention / Treatment
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* Biological: Cytokine-induced Killer Cells
* Drug: Tegafur-Gimeracil-Oteracil Potassium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No less than 18 years old Karnofsky Performance Status over 60 Life expectancy more than three months Pathological diagnosed as pancreatic epithelial cell carcinoma Recurrence after surgery or unresectable No experienced chemotherapy or the interval between the last adjuvant chemotherapy and relapse is at least 6 months Measurable lesions (by CT or MRI) No serious mental disorders Adequate organ and bone marrow functions No other serious and the conflict diseases(such as autoimmune diseases, immunodeficiency, organ transplantation) No other malignant tumor history Informed consent and willing to participate in this study Exclusion Criteria: Received immunosuppressants or glucocorticoid treatment Uncontrolled severe infection or unhealed wound caused by suppurative inflammation Heart disease, insufficient heart function, II degree heart block or occurred myocardial infarction in 6 months Poor pulmonary functions caused by interstitial lung disease and pulmonary reserve volume under 80% of the expected value Other malignant tumor history Transaminase>2.5ULN or bilirubin>3ULN or creatinine >1.25ULN Pregnant or lactating women Obvious bleeding tendency Participated other clinical trails in 1 month Other unsuitable conditions: HIV infection, intravenous drug abusers, etc

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: CIK combined chemotherapy<br>Autologous Cytokine induced killer cells combined Tegafur, Gimeracil and Oteracil Potassium Capsules. After 2 to 4 days of chemotherapy, about 5×10９autologous cytokine induced killer cells are transfused into the vein of the patients in one hour. | Biological: Cytokine-induced Killer Cells<br> <br> Drug: Tegafur-Gimeracil-Oteracil Potassium<br> <br> |
| Active Comparator: Chemotherapy<br>Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w | Drug: Tegafur-Gimeracil-Oteracil Potassium<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | From the date of randomization to the date of death from any cause up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | From the date of randomization to the date of first documented progression up to 24 months | 
| Quality of life assessed by Questionnaire |  | one year by questionnaire | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CIK, Chemotherapy, Pancreatic Cancer