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| Name | Class |
|---|---|
| Duke University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-PD-1 plus DC-CIK | Experimental |
| |
| Anti-PD-1 alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-PD-1 plus DC-CIK | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival of the participants(OS) | From starting date of anti-PD-1 antibody treatment until date of death from any cause | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
| The changes in immune-response specific patient-reported outcomes(irPRO) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory biomarkers | To investigate the relationship of ctDNA,tumor related antigen peptides, T cell metaboic activity,and microbial bacteria with clincial outcomes | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University Cancer Center/Beijing Shijitan Hospital | Beijing | Beijing Municipality | 100038 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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|
| Anti-PD-1 alone | Biological | Anti-PD-1 antibody treatment: Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal. |
|
To assess the irPRO scale ratings prior to and after the cancer immunotherapy |
| 24 months |
| Treatment-related adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 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 | 24 months |