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To evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in EGFR/ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy.
This study is a clinical intervention study. The patients who comfirm the criteria will be treated with tislelizumab plus metronomic oral vinorelbine. The patients will be followed up until the tumor progressed, and the efficacy (PFS, ORR, DCR) of tumor therapy were evaluated. Drug administration regimen: tislelizumab 200mg intravenous drip once every 3 week3; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tislelizumab plus metronomic oral vinorelbine | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tislelizumab and metronomic oral vinorelbine | Drug | tislelizumab 200mg intravenous drip once every three weeks; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression-free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | up to 12 months |
| DCR | Disease Control Rate | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian cancer hospital | Fuzhou | Fujian | China |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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| AE | Number of Participants Who Experienced an Adverse Event | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |