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PD-1/PD-L1 blockades have attracted much attention in the treatment of lung cancer, however only a small set of patients can benefit from this kind of immunotherapy. At present, the expression level of PD-L1 is the major factor to evaluate the prognosis,, which is highly dependent on the quality of tissue samples and detection methods.Therefore, finding predictive markers,especially based on liquid biopsy, to screen the patients who will benefit most from PD-1/PD-L1 blockades is an urgent issue in immunotherapy for lung cancer. Tumor autoantibodies, as immune response products of the immune system to tumor antigens, are of great significance in tumor diagnosis. Till now, the relationship between tumor autoantibodies and immunotherapy efficacy has not been reported. In this study, 200 non-small cell lung cancer patients will be enrolled with baseline serum tumor autoantibodies detection, then treated with PD-1 blockade. The purpose of this study is to explore the correlations of serum autoantibodies expression and efficacy of PD-1 inhibitor, so that to identify new markers for predicting the efficacy of PD-1/PD-L1 immunotherapy in non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | All participants will be detected for antoantibodies and then treated with PD-1 blockade. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum tumor autoantibody detection | Diagnostic Test | All enrolled patients will be tested for ten kinds of tumor autoantibodies using peripheral blood before PD-1 bloackade treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The correlations of tumor autoantibodies and PFS/ORR of PD-1 blockade treatment. | To analyze the relationships of serum tumor autoantibody expression and PFS (progression-free survival) and ORR ( objective response rate) of enrolled patients treated with PD-1 blockade. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The correlations of tumor autoantibodies and OS/DCR of PD-1 blockade treatment. | To analyze the relationships of serum tumor autoantibody expression and OS (overall survival) and DCR (disease control rate) of enrolled patients treated with PD-1 blockade. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with advanced non-small cell lung cancer, PD-L1 expression ≥1%, EGFR/ALK/ROS1 wild type will be studied. The serum autoantibodies will be detected before PD-1 blockade treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Zhang, MD | Contact | 13501878890 | zhangjie2172@163.com |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |