Renal Cell Carcinoma
Conditions
Brief summary
The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells (DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with renal cell carcinoma. Experimental recombinant adenovirus-transfected DC, which engineered to express MUC1 and Survivin are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.
Interventions
BIOLOGICALadenovirus-transfected DC + CIK
adenovirus-transfected DC vaccine plus CIK cells
Sponsors
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years at time of consent * Histopathologically confirmed diagnosis of renal cell carcinoma * Received standardized treatment of renal cell carcinoma * Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks * KPS (Karnofsky performance scale) \>60 * Patient's written informed consent * Predicted survival \>3 months * No severe viral or bacterial infections
Exclusion criteria
* Receiving chemotherapy, radiotherapy or other therapy * Patients with other malignancies and infectious diseases * Pregnant and breast-feeding patient * Currently participating in another clinical trial * Unfit for participating in this clinical trial in investigators' opinions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective tumor response (CR+PR) as measured by RECIST criteria | 4 weeks after DC/CIK treatment |
Secondary
| Measure | Time frame |
|---|---|
| number of participants with adverse events | 3 days within DC/CIK treatment |
Countries
China
Outcome results
None listed