The purpose of this study is to compare the clinical efficacy and toxicity of anti-PD-1 monoclonal antibody alone with anti-PD-1 monoclonal antibody plus autologous dendritic cells-cytokine induced killer cell (DC-CIK) immunotherapy in advanced tumor patients.Furthermore,to characterize response to therapy we intent to evaluate the role of cell-free DNA (cfDNA) and immune repertoire based on the next generation sequencing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Anti-PD-1 antibody treatment: Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal. DC-CIK Immunotherapy: Mononuclear cells were collected aseptically with blood cell separator composition apheresis, and cultured DC-CIK cells for 10-14 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of DC-CIK Immunotherapy along with 4 dosage of anti-PD-1 antibody treatment. If the evaluation of the treatment is partial response or stable disease, additional cycles were eligible.
Anti-PD-1 antibody treatment: Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.
Capital Medical University Cancer Center/Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
Overall survival of the participants(OS)
From starting date of anti-PD-1 antibody treatment until date of death from any cause
Time frame: 24 months
Progression-free survival of the participants(PFS)
From starting date of anti-PD-1 antibody treatment until date of until the date of first documented disease progression or date of death from any cause, whichever comes first
Time frame: 24 months
The changes in immune-response specific patient-reported outcomes(irPRO)
To assess the irPRO scale ratings prior to and after the cancer immunotherapy
Time frame: 24 months
Treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 24 months
The changes in patient self-reported quality of life
To assess the EORTC QLQ-C30 scale ratings prior to and after the cancer immunotherapy
Time frame: 24 months
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