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In lung cancer, ensartinib is effective in improving the prognosis of ALK positive /MET exon 14 skipping patients. However, patients with ALK positive /MET14 exon skipping non-lung cancer solid tumors have limited treatment options in the absence of standard treatment. We hope to bring a new effective and safe treatment option to these patients more efficiently.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ensartinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ensartinib | Drug | ensartinib 225mg ,PO,QD,until disease progression or intolerable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | time to progression or Intolerable toxicity occurred | 2 years |
| Overall responce rate | Proportion of patients with CR/PR response in the total population | 1year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate | Proportion of patients with CR/PR/SD response in the total population | 1year |
| Overall survival | time to death | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowei Wei | Contact | 025-52271000 | gswxw@126.com |
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| ID | Term |
|---|---|
| C000629294 | ensartinib |
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| Duration of responce | time from first assessment of CR or PR to the first assessment of PD or death | 3 years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | The safety of Ensartinib treatment will be assessed according to CTCAE v5.0 criteria observed over the whole treatment period. | 3 years |