A randomized controlled study to compared the clinical effects and safety of immunotherapy with dendritic cells and cytokine-induced killer cells administered with anti-PD-1 antibody in advanced NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.
Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital
Beijing, China
Progression-free survival of the participants
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: 12 months
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
Assessment of Patient- Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PROCTCAE)
To assess and compare the PRO-CTCAE by patients receiving immunotherapy
Time frame: 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 24 months
Molecular Tumor Burden Index
Using mutation detection in ctDNA by liquid biopsy to assess tumor dynamics
Time frame: 24 months
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