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The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.
The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.
Step 1: All the lung cancer patients treated with Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy were enrolled in this study.
Step 2: All the adverse events were evaluated by principal investigator. Step 3: All the blood and FFPE samples were collected for further anaysis. Step 4: Correlation between adverse events and gene profile was analysis. Step 4: Predict model was construted with AI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors | Experimental | Lung Cancer patients treated with Chemotherapy plus Immune Checkpoint Inhibitors. |
|
| Cohort B: Immune Checkpoint Inhibitors monotherapy | Experimental | Lung Cancer patients treated with Immune Checkpoint Inhibitors monotherapy. |
|
| Cohort C: Chemotherapy Group. | Experimental | Lung Cancer patients treated with Chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed plus Pembrolizumab | Drug | Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. Pemetrexed, 500mg/m2, ivgtt, every 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between Adverse events (AEs) and gene profile | Correlation between Adverse events (AEs) and gene profile | Time from first subject dose to study completion, or up to 36 month |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) rate according to CTCAE 5.0 | Adverse events (AEs) rate according to CTCAE 5.0 | Time from first subject dose to study completion, or up to 36 month |
| Correlation between Adverse events (AEs) and survival outcome |
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Inclusion Criteria:
6. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1.
Exclusion Criteria:
Any conditions can not match for the Inclusion Criteria, includign do not have the data to perform Adverse Events evalutation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongchang Zhang, MD | Contact | +8613873123436 | 7+861383123436 | zhangyongchang@csu.edu.cn |
| Nong Yang, MD | Contact | +8613873123436 | +8613873123436 | yangnong0217@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongchang Zhang, MD | Hunan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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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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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| C582435 | pembrolizumab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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|
| Pembrolizumab | Drug | Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. |
|
| Pemetrexed | Drug | Pemetrexed, 500mg/m2, ivgtt, every 21 days etc. |
|
|
Correlation between Adverse events (AEs) and survival outcome
| Time from first subject dose to study completion, or up to 36 month |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |