Study objectives are to investigate the efficacy and safety of activated autologous dendritic cells (DCs) in treatment of gastric cancer. DCs are activated by the proteins from autologous tumor cell membrane and cytokines in vitro. The efficacy endpoints include objective response, immune-cell response, recurrent rate after a radical surgery, progression-free survival and overall survival, and the safety endpoints include adverse events, laboratory tests, ECG, ECOG-PT, etc.
Study objectives are to investigate the efficacy and safety of activated autologous dendritic cells (DCs) in treatment of gastric cancer. The autologous DCs are collected and enriched from peripheral blood, and then are activated by the proteins from autologous tumor cell membrane and cytokines in vitro. The efficacy endpoints include objective response, immune-cell response, recurrent rate after a radical surgery, progression-free survival and overall survival, and the safety endpoints include adverse events, laboratory tests, ECG, ECOG-PT, etc. All patients will be followed up for at least 2 years after treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
autologous dendritic cells are collected and enriched from 50 ml of peripheral blood, then activated by autologous tumor cell membrane proteins. Then the activated DCs are iv infused in 21 days after a radical surgery.
Only radical surgery is given to the control group
Lanzhou University Second Hospital
Lanzhou, Gansu, China
RECRUITINGprogression-free survival
Time to progression/death or censored time
Time frame: 3 years
recurrent rate
the rate of cancer recurring after surgery
Time frame: 3 years
overall survival rate
time to death or censored time
Time frame: 5 years
immune-cells response
CD4/CD8 T lymphocyte percentage change
Time frame: 3 months
Adverse event rate
Adverse event rate
Time frame: 3 months
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