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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
ensartinib 225mg ,PO,QD,until disease progression or intolerable toxicity
progression-free survival
time to progression or Intolerable toxicity occurred
Time frame: 2 years
Overall responce rate
Proportion of patients with CR/PR response in the total population
Time frame: 1year
Disease control rate
Proportion of patients with CR/PR/SD response in the total population
Time frame: 1year
Overall survival
time to death
Time frame: 3 years
Duration of responce
time from first assessment of CR or PR to the first assessment of PD or death
Time frame: 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.
Time frame: 3 years
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