Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer
NCT ID: NCT03002831
Last Updated: 2020-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
13 participants
INTERVENTIONAL
2016-11-30
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CIK combined chemotherapy
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.
Cytokine-induced Killer Cells
Tegafur-Gimeracil-Oteracil Potassium
Chemotherapy
Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w
Tegafur-Gimeracil-Oteracil Potassium
Interventions
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Cytokine-induced Killer Cells
Tegafur-Gimeracil-Oteracil Potassium
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Quanli Gao, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Locations
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Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China
Countries
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References
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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.
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.
Other Identifiers
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HenanCH CIK02
Identifier Type: -
Identifier Source: org_study_id
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