pancreatic cancer
Conditions
Interventions
Case series:iNKT cells and CD8+T cells
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. Histological or cytological confirmation of pancreatic ductal adenocarcinoma; 3. Progression disease during or within 6 months after standard first-line chemotherapy; Recurrence within 6 months after standard adjuvant chemotherapy; 4. According to the RECIST 1.1 standard for solid tumor efficacy evaluation criteria, patients have measurable target lesions; 5. Recover from the reversible toxicity of previous therapies; 6. KPS=70 scores; 7. BMI = 18.5; 8. VAS pain score = 3 scores; 9. Estimated survival period = 12 weeks; 10. Blood routine examination: white blood cells = 3.5 ×10^9/L; neutrophils ANC = 1.5 ×10^9/L; platelets PLT = 100 ×10^9/L; hemoglobin Hb = 90g/L; 11. Biochemical examination: total bilirubin = 1.5 × ULN; aspartate aminotransferase and alanine aminotransferase = 2.5 × ULN (liver metastasis patients = 5 ×ULN); albumin level = 35g/L; serum creatinine = 2mg/dL; creatinine clearance rate = 60ml/min; phosphorus =LLN; potassium =LLN; 12. Normal electrocardiogram or abnormal electrocardiogram without clinical significance; LVEF = LLN; 13. All women of childbearing age and all male subjects are required to agree to use effective contraception from the start of the study until 6 months after the last cellular immunotherapy; 14. Subjects volunteered to participate in the study, signed informed consent; 15. Subjects were well-adhered to follow-up.
Exclusion criteria
Exclusion criteria: 1. Central nervous system metastasis; 2. Ascites patients requiring clinical intervention; 3. Suffering from other malignant tumors; 4. Suffering from myelodysplastic syndrome; 5. Suffering from hereditary diseases, metabolic diseases; 6. Serious protein allergies or autoimmune diseases; 7. Have received bone marrow, stem cell or organ transplantation; 8. Use of immunosuppressive drugs within 3 months prior to enrollment; 9. Human immunodeficiency virus (HIV) infection, active viral hepatitis, tuberculosis, etc.; 10. Have had myocardial infarction, unstable angina, stroke and uncontrollable arrhythmia; 11. Have internal medical diseases that do not meet the conditions of immunotherapy, such as inflammation, dysfunction of vital organs such as heart, liver, lung, kidney and blood; 12. Pregnant or lactating women, or who do not agree to use effective contraception from the time of entry into the study until 6 months after the last cellular immunotherapy; 13. Have a mental or addictive disorder that may affect the ability to sign their informed consent; 14. Those who cannot be obtained their immunological evaluation and follow-up evaluation; 15. Other circumstances juged by the investigator that are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival;Objective response rate;Quality of life; | — |
Countries
China
Contacts
Public ContactJianqing Xu
Shanghai Public Health Clinical Center
Outcome results
None listed