castration resistance prostate cancer
Conditions
Interventions
two groups:autologous dendritic cell vaccines
Sponsors
Jiangsu Decon Bio-Sci-Technology Co. Ltd
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The diagnosis of patients with castration resistance prostate cancer; 2. plasma testosterone less than 50ng/ml; 3. Two weeks interval elevated PSA 3 times in a row; 4. Resistance to male drug withdrawal treatment more than 4 weeks; 5. PSA progress during secondary endocrine therapy; 6. Bone or soft tissue metastasis lesions have progress; 7. KPS score more than at least 60 points, estimated survival of more than 6 months; 8. Adequate organ function, meeting the following criteria: absolute neutrophil count (ANC) more than 1.5*10^9/L, Platelet count more than at least 80*10^9/L, Hemoglobin more than at least 100g/L; ALT and AST less than at least 2.5 times the upper limit of normal, CCr more than at least 60ml/min or Cr less than at least 1.5 times the upper limit of normal; 9. No serious mental illness and no serious heart, liver, kidney, lung function is not complete, not combined with other deadly diseases; 10. Voluntary participation in the clinical trials and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Serious or uncontrolled systemic disease or any instability of systemic disease (including but not limited to active infection, grade 3 hypertension, unstable angina pectoris, Congestive heart failure, grade III or IV cardiac disease, serious cardiac arrhythmias, liver and kidney function disorders or metabolic diseases), history of neurological or mental disorders, etc.; 2. Patients received organ transplantation; 3. Patients with history of autoimmune disease, for example SLE, rheumatic arthritis and angiitis; 4. Patients received other clinical trials in 3 months; 5. Unwilling to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cytokine levels;tumor markers;DTH;CD8+IFN-gama+T%;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life;lymphocyte subsets; | — |
Countries
China
Contacts
Public ContactShi Hongzhen
Outcome results
None listed