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The purpose of the study is to evaluate the safety and efficacy of camrelizumab combined with chemotherapy in the first-line treatment of advanced in NSCLC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carrelizumab + chemotherapy + apatinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carrelizumab + chemotherapy + apatinib | Drug | Subjects will receive 200 mg of karizumab every three weeks,Pemetrexed 500 mg / m2 was given on the first day of each cycle,Every three weeks was a period of administration,Carboplatin AUC 5 was given on the first day of each cycle and every three weeks was a cycle,Paclitaxel 175 mg / m2 was given on the first day of each cycle, and every three weeks was an administration cycle,with intravenous drip,Apatinib, 250 mg, oral, once a day (PO, QD), every 3 weeks as a cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | From the date Into this study to tumor progression or death for any | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival, | The time from the beginning of treatment to the death of the subject due to various reasons, calculated by the intended treatment population (ITT) | 2 Year |
| Objective response rate |
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Inclusion Criteria:
1) The blood routine examination standard should meet the requirements (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimulating factors): A. Hemoglobin (HB) ≥ 90 g/l; B. Neutrophil number (ANC) ≥ 1.5 × 109/L; C. Platelet count (PLT) ≥ 100 × 109/L; 2) Biochemical examination shall meet the following standards: A. TBIL was lower than 1.5 upper limit of normal value (ULN); B. ALT and AST were less than 2.5 ulin, but < 5 uld in liver metastasis; C. The serum creatinine (CR) < 1.5 ULN or the clearance rate of endogenous creatinine was more than 60ml / min (Cockcroft Gault formula); D. The results of routine urine test showed that uro was less than 2+ or 24 hours urinary protein was less than 1G; 8. Men and women of gestational age must agree to take adequate contraceptive measures throughout the study period and within 6 months after the treatment.
Sign written informed consent, and it is expected to be in good compliance with the research plan.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ying Hu, doctor | Contact | 01089509304 | hygzz2004@163.com | |
| li Ma, doctor | Contact | 01089509324 | silenceli2013@163.com |
| Name | Affiliation | Role |
|---|---|---|
| ying Hu, doctor | Beijing Chest Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D004358 | Drug Therapy |
| C553458 | apatinib |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
it is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR.
| 2 Year |
| Disease Control Rate | the rate of CR, PR plus SD | 2 Year |
| Duration of Response | Cr or PR to the first assessment of PD or death from any cause | 2 Year |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |