Clinical trial · Interventional
Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer
Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer: A Prospective, Randomized, Open, Single Center Phase II Study
NCT03002831CI-TRIAL-00044398terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study halted prematurely and will not resume
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytokine-induced Killer Cells | Biological | — | UNRESOLVED |
| Tegafur-Gimeracil-Oteracil Potassium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CIK combined chemotherapy
- description
- 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.
- interventionNames
- Biological: Cytokine-induced Killer Cells
- Drug: Tegafur-Gimeracil-Oteracil Potassium
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w
- interventionNames
- Drug: Tegafur-Gimeracil-Oteracil Potassium
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTImaoka 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. PMID 26741729
- RESULTWang 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. PMID 26842696