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Study halted prematurely and will not resume
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIK combined chemotherapy | Experimental | 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. |
|
| Chemotherapy | Active Comparator | Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytokine-induced Killer Cells | Biological |
| ||
| Tegafur-Gimeracil-Oteracil Potassium |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From the date of randomization to the date of death from any cause up to 36 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quanli Gao, Ph.D. | Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26741729 | Result | Imaoka H, Kou T, Tanaka M, Egawa S, Mizuno N, Hijioka S, Hara K, Yazumi S, Shimizu Y, Yamao K. Clinical outcome of elderly patients with unresectable pancreatic cancer treated with gemcitabine plus S-1, S-1 alone, or gemcitabine alone: Subgroup analysis of a randomised phase III trial, GEST study. Eur J Cancer. 2016 Feb;54:96-103. doi: 10.1016/j.ejca.2015.11.002. Epub 2015 Dec 30. | |
| 26842696 |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Drug |
|
| Result |
| Wang Z, Liu Y, Li R, Shang Y, Zhang Y, Zhao L, Li W, Yang Y, Zhang X, Yang T, Nie C, Han F, Liu Y, Luo S, Gao Q, Song Y. Autologous cytokine-induced killer cell transfusion increases overall survival in advanced pancreatic cancer. J Hematol Oncol. 2016 Feb 3;9:6. doi: 10.1186/s13045-016-0237-6. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |