The purpose of this study is to investigate the clinical efficacy and toxicity of anti-PD-1 monoclonal antibody plus autologous dendritic cells-cytokine induced killer cell (DC-CIK) immunotherapy combined with hyperthermia in advanced malignant mesothelioma patients.Furthermore,to characterize response to therapy,the investigators intent to explore the predictive biomarker for this regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.
Mononuclear cells were collected from 50ml peripheral blood , and cultured DC-CIK cells for 15-20 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.
Hyperthermia for 40 minutes, with maximum temperature setted on 42℃ ± 0.5℃ as upper limit, twice a week since the 1st week of pembrolizumab for a total of 10 times.
Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital
Beijing, China
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
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 (PRO-CTCAE)
To assess and compare the PRO-CTCAE by patients receiving immunotherapy
Time frame: 24 months
Safety (adverse events)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 24 months
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