Pancreatic and Cholangiocarcinoma
Conditions
Interventions
single-arm:NK cells
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with pancreatic cancer or cholangiocarcinoma diagnosed by pathology and imaging evidence such as CT and MRI; 2. Patients with advanced cholangiocarcinoma or pancreatic cancer; 3. Patients planning to receive treatment with gemcitabine and tegafur; 4. Must have at least one evaluable lesion judged according to the RECIST V1.1 standard, see Appendix 2; 5. Male or female, aged 18-75 years; 6. Karnofsky score = 80, see Appendix 4; 7. The estimated survival period is = 3 months; 8. Absolute neutrophil count (ANC) = 1.5 × 10^9 / L and platelet count = 80 × 10^9 / L and hemoglobin = 9 g / dL; 9. Total bilirubin = 1.5 times the upper limit of normal (ULN); AST and ALT = 2.5 times the upper limit of normal (ULN); alkaline phosphatase = 5 times the upper limit of normal (ULN); 10. Serum creatinine = 1.5 times the upper limit of normal (ULN) or calculated creatinine clearance = 50 mL / min; 11. The electrocardiogram is basically normal, the cardiac ejection fraction is >50%, and there is no unhealed wound on the body; 12. Patients with negative HIV, HBV, and HCV tests; 13. Have at least one healthy sibling or relative of the child, and the relative is willing to provide his or her peripheral blood according to the test needs; 14. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients known to be allergic to biological products or allergic to the chemotherapy drugs gemcitabine and tiggio capsules; 2. There are serious uncontrolled acute infections, or suppurative and chronic infections, and the wounds are prolonged; 3. Those with serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension; 4. Suffering from uncontrollable neurological, psychiatric or psychiatric disorders, poor compliance, can not cooperate with and describe the treatment response; primary brain tumor or central nervous system tumor disease is not controlled, with obvious intracranial hypertension or nerve Psychotic symptoms; 5. Those with bleeding tendency; 6. Patients who are taking drugs or have drug dependence; 7. Patients with a history of organ transplantation and hematopoietic stem cell transplantation; 8. Have other immune diseases, or long-term use of immunosuppressants or steroids, or use immunosuppressive drugs in the first 3 months of the study, or receive a glucocorticoid system one week before entering the study; 9. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy tests within 7 days prior to study enrollment and must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 10. Other circumstances that the investigator considers to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 4-cycle Objective Efficiency;Overall Survival;Changes in quality of life;4-cycle Tumor Marker; | — |
Countries
China
Contacts
Public ContactJie Ma, Yunbo Zhao
Second Department of Beijing Public Security Hospital
Outcome results
None listed