DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma
This trial is active, not recruiting.
|Condition||renal cell carcinoma|
|Treatment||adenovirus-transfected dc + cik|
|Phase||phase 1/phase 2|
|Sponsor||Affiliated Hospital to Academy of Military Medical Sciences|
|Start date||July 2013|
|End date||December 2016|
|Trial size||30 participants|
|Trial identifier||NCT01924156, 307-CTC-DC/CIK-RCC|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
adenovirus-transfected autologous DC vaccine plus CIK cells
objective tumor response (CR+PR) as measured by RECIST criteria
time frame: 4 weeks after DC/CIK treatment
number of participants with adverse events
time frame: 3 days within DC/CIK treatment
Male or female participants at least 18 years old.
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
|Official title||Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Renal Cell Carcinoma: a Phase I/II Study|
|Principal investigator||Hu Chen, M.D., Ph.D.|
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