Renal Cancer Metastatic Clinical Trial
Official title:
A Study of Anti-PD-1( Pembrolizumab) Combinations of D-CIK (Cytokine-induced Killer Cells Are Stimulated Using Mature Dendritic Cells) Immunotherapy and Axitinib in Advanced Ranal Carcinoma
Phase II clinical trial to investigate the safety, clinical activity and toxicity of combinations of D-CIK and low dose anti-PD-1 antibody in patients with metastatic renal cell carcinoma treated with axitinib.
This is a phase II, single arm study to investigate the safety and efficacy of
pembrolizumab-activated autologous D-CIK cells (CIK:Cytokine-induced killer, D-CIK:CIK cells
are stimulated using mature dendritic cells) with Axitinib in patients with advanced kidney
cancer.
Heparinized peripheral blood was obtained from participants over a 1-week period.
PBMCs(Peripheral blood mononuclear cells) were separated by Ficoll-Hypaque gradient
centrifugation, suspended in X-VIVO 15 serum-free medium, and culture with 1000 U/ml
rhIFN-γfor the first 24 h, followed by stimulation with 100 ng/ml OKT-3 , 1000 U/ml rhIL-2
and 100 U/ml IL-1α to activate the CIK.Dendritic cells were incubated with CIK. Fresh medium
containing 1000 U/ml rhIL-2 was added every 2 days and the cell density was maintained at
2×10^6 cells/mL.D-CIK were harvested, washed, and resuspended after culture for 14 days.
Before cell transfer,D-CIK were incubated with anti-PD-1 antibody(Pembrolizumab (Merck & Co.,
Inc.) is a humanized IgG4 anti-PD-1 monoclonal antibody that binds to PD-1 to prevent it from
engaging with PD-L1 or PD-L2.), and a fraction of the D-CIK were collected to assess their
number, phenotype, and viability of cells, and to test for possible contamination by
bacteria, fungi, or endotoxins. Then, autologous D-CIK (1.0-1.5*10^10 cells) were transferred
to patients via intravenous infusion.
The present study was designed with Simon's best two stage study to explore the efficacy and
safety of low-dose pembrolizumab in the treatment of patients with advanced renal cancer by
D-CIK re-transfusion combined with Axitinib in vitro. The expected effective rate of the
combined treatment is set at 60%, and if the effective rate is less than 30%, the effective
rate of the combined treatment is considered to be at an undesirable level. The best
two-stage design is 3/8, 10/24. In the first stage, 8 patients need to be treated. If the
number of effective cases is less than 3, the combined treatment is deemed ineffective and
the trial needs to be terminated. If the number of effective cases is more than 3, the phase
II trial will be continued, and a total of 24 subjects need to be included.
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