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Small cell lung cancer is a highly malignant tumor, and its first-line treatment has not broken through platinum-containing dual-drug chemotherapy in the past 30 years. Because small cell lung cancer has the characteristics of easy resistance after first-line chemotherapy, increased difficulty in treatment after resistance, and poor efficacy of second-line treatment, how to formulate a plan that can control tumor progression to the greatest extent has become a hot issue in recent research. Recently, immunotherapy and targeted therapy have made breakthrough progress in small cell lung cancer, but its efficacy still needs to be further improved. As immune combined chemotherapy combined with targeted therapy first achieved good results in other tumors, this study aims to explore a longer disease-free survival time and higher overall survival rate of patients with small cell lung cancer through immunotherapy combined with targeted therapy combined with chemotherapy. Program to bring new hope to patients. At the same time, this study will evaluate the safety of the program, explore the prognostic indicators that may exist in the treatment, and provide new inspiration for subsequent patient selection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Experimental:Camrelizumab combined with Apatinib, Etoposide and Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab combined with Apatinib, Etoposide and Cisplatin | Drug | Camrelizumab combined with Apatinib, Etoposide and Cisplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-year overall survival rate(1-year OS%) | 1-year OS%, determined by RECIST V1.1 standard which means proportion of outcome events occurring within one year from the start of the trial | up to 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival(PFS) | PFS, determined by RECIST V1.1 standard which means the time from the beginning of the organised clinical trial to the onset of tumors (in any aspect) or death due to any reason | up to approximately 4-6 months |
| overall survival(OS) |
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Inclusion Criteria:
Blood routine: WBC≥3.0 × 109/L;ANC≥1.5 × 109/L;PLT≥100× 109/L;HGB≥9.0 g/dL; Liver function: TBIL≤1.5 × ULN, AST≤2.5 × ULN, ALT≤2.5 × ULN (for subjects with liver metastases, AST≤5×ULN, ALT≤5 × ULN) Renal function: Cr≤1.5 × ULN or CrCl ≥50 mL/min Coagulation function: INR≤1.5, APTT≤1.5 ×ULN
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiong Chen | Contact | 13625082108 | +86 | zpccx81@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiong Chen | The 900th Hospital of Joint Logistic Support Force | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 900th Hospital of Joint Logistic Support Force | Recruiting | Fuzhou | Fujian | 350025 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| D005047 | Etoposide |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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OS, determined by RECIST V1.1 standard which means the time from randomization of patients in clinical trials to death due to any cause. |
| up to approximately 18 months |
| Objective Response Rate(ORR) | ORR, determined by RECIST V1.1 standard which refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time | up to 1-year |
| disease control rate(DCR) | DCR, determined by RECIST V1.1 standard which refers to proportion of patients whose tumors have shrunk or stabilized for a certain period of time | up to 1-year |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |