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The goal of this observational study is to evaluate the efficacy and safety of oral metronomic vinorelbine and PD-1 inhibitors in elderly patients with unoperable, locally advanced or metastatic non-small-cell lung cancer. The primary end point was objective response rate (ORR), and the second end points included disease control rate (DCR), progression-free survival (PFS), and safety. Participants over 65 years old, received oral metronomic vinorelbine 40mg every week (20mg for patients over 80 years old), combined with PD-1 inhibitors every 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The goal of this observational study is to evaluate the efficacy and safety of oral metronomic vinor | Participants over 65 years old, received oral metronomic vinorelbine 40mg every week (20mg for patients over 80 years old), combined with PD-1 inhibitors every 3 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| objective response rate(ORR) | CR+PR/All patients(%) | at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| disease control rate (DCR) | CR+PR+SD/All patients(%) | at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 years |
| progression-free survival (PFS) | PFS was calculated from treatment initiation to disease progression or death |
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Inclusion Criteria:
1) All patients are histologically or cytologically confirmed non-small cell lung cancer. Genetic testing identifies no driver gene mutations.
2) Male or female, age ≥ 65 years 3) Patients had not received first-line treatment. 4) KPS score ≥ 70 points (ECOG score 0-1 points), the expected survival ≥3 months; 5) No dysfunction of major organs. EcG, liver function, renal function, and blood count tests before treatment are normal or basically normal, but must meet the following experimental results:
Blood routine test:
Leukocyte WBC≥3.5×109/L; Neutrophil count (ANC) ≥ 1.5×109/L; Platelet (PLT) ≥ 80×109/L;
Blood biochemical test:
Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal values; Alanine aminotransferase (ALT/SGPT) and alanine transaminases (AST/SGOT) ≤ 2.5 times the normal high value (ULN), or ≤ 5 times the upper limit of normal value in patients with liver metastases; Serum creatinine (Cr) ≤ 1.5 times the upper limit of normal values;
Cardiac function test: 50% of the left ventricular ejection function of the heart >; 6) The subject has good compliance, and can cooperates with follow-up.
Exclusion Criteria:
previously treated
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Patients over 65 years old with unoperable, locally advanced or metastatic non-small-cell lung cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maojing Guan, Doctor | Contact | 021-0551-63773020 | guanmaojing0623@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Qingming Shi, Doctor | Anhui Chest Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Chest Hosptial | Recruiting | Hefei | Anhui | 230022 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| at the end of every 2 cycles(each cycle is 21 days),through study completion, an average of 2 years |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |