Kidney cancer
Conditions
Interventions
low-dose group:Autoimmune cell
Medium dose group:Autoimmune cell
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Metastatic renal cancer was diagnosed by histological examination as unresectable metastatic renal cancer with disease progression or intolerance after 1 line systemic treatment Patients; Note: Definition of intolerance: it refers to the occurrence of grade 3-4 adverse reactions after drug treatment, which are rejected by patients Chemotherapy again. 3. RECIST1.1 had a measurable lesion; 4. ECOG score is 0 or 1; 5. Expected survival time 3 months; 6. Blood routine examination during screening: neutrophil count 1.5×10^9/L, lymphocyte count 1.1×10^9/L, platelet count80 x 10^9/L or higher; 7. Important organ functions: cardiac ultrasound indicated that the ejection fraction of the heart was 50%, and there was no obvious abnormality in the electrocardiogram; Blood oxygen filling Degree or higher by 90%; Creatinine clearance CG formula 50ml/min; ALT and AST 1.5XULN (liver metastasis, then ALT and AST can be relaxed to 2.5XULN); Serum bilirubin 1.5XULN; 8. Pulmonary embolism was assessed as normal (Pauda score and risk stratification were used in internal medicine); 9. Men who are fertile or women who are at risk of becoming pregnant must use highly effective contraceptives during the trial(e.g., oral contraceptives, intrauterine contraceptives, abstinence or barrier contraceptives combined with spermicide), and are being treated Continue contraceptive use for 3 months after termination; 10. Sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients who have had organ transplants; 3. Less than 4 weeks after the end of the previous anti-tumor treatment including cytotoxic drugs, targeted therapy and cytokines; 4. Have used immunosuppressive agents (such as azathioprine, 6-mercaptopurine, cyclosporine, etc.); Long-term use of corticosteroids Hormone; Note: except for 3 months after withdrawal of ivermox from > 5. Previous use of dc-cik or CIK cells, autologous RAK/LAK cells or other adoptive immunotherapy; 6. A history of other malignant diseases in the last 5 years (except cured skin cancer and carcinoma in situ of the cervix); 7. Uncontrolled epilepsy, central nervous system diseases, cerebrovascular accidents, or other uncontrollable accompanying diseases; History of divine disorders; 8. Clinically severe heart disease (NYHA), grade II or more severe congestive heart failure or severe arrhythmia requiring drug intervention; 9. Interstitial lung disease 2; 10. Fever or infection within two weeks; 11. Suffering from autoimmune diseases, including uncontrollable hypothyroidism and hyperthyroidism; 12. Positive for hepatitis b surface antigen; Positive antibodies for hepatitis C, AIDS or syphilis; 13. Is being treated with phenytoin, warfarin and fluorouracil; 14. Allergic to any interferon and interleukin-2 preparations; 15. Participate in other tests within 4 weeks before enrollment; 16. Poor compliance or situations in which the researcher considers it inappropriate to be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security; | — |
Countries
China
Contacts
Public ContactJie Ma
Beijing Hospital
Outcome results
None listed