Advanced Cancer
Conditions
Keywords
CIK, Chemotherapy, Pancreatic Cancer
Brief summary
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
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.
Interventions
Sponsors
Henan Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. No less than 18 years old 2. Karnofsky Performance Status over 60 3. Life expectancy more than three months 4. Pathological diagnosed as pancreatic epithelial cell carcinoma 5. Recurrence after surgery or unresectable 6. No experienced chemotherapy or the interval between the last adjuvant chemotherapy and relapse is at least 6 months 7. Measurable lesions (by CT or MRI) 8. No serious mental disorders 9. Adequate organ and bone marrow functions 10. No other serious and the conflict diseases(such as autoimmune diseases, immunodeficiency, organ transplantation) 11. No other malignant tumor history 12. Informed consent and willing to participate in this study
Exclusion criteria
1. Received immunosuppressants or glucocorticoid treatment 2. Uncontrolled severe infection or unhealed wound caused by suppurative inflammation 3. Heart disease, insufficient heart function, II degree heart block or occurred myocardial infarction in 6 months 4. Poor pulmonary functions caused by interstitial lung disease and pulmonary reserve volume under 80% of the expected value 5. Other malignant tumor history 6. Transaminase\>2.5ULN or bilirubin\>3ULN or creatinine \>1.25ULN 7. Pregnant or lactating women 8. Obvious bleeding tendency 9. Participated other clinical trails in 1 month 10. Other unsuitable conditions: HIV infection, intravenous drug abusers, etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | From the date of randomization to the date of death from any cause up to 36 months |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed