The purpose of this study is to evaluate the efficacy and safety of Chidamide with EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer
(1)The efficacy of the regimen is evaluated by objective remission rate, disease control rate, progress free survival, duration of remission, overall survival, time to progression. Safety is monitored by vital signs, blood routine test, liver function, kidney function and electrolytes level, ECG, and cardiac ultrasonography. All the data is documented by CRF form, and carefully preserved.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Chidamide and EGFR-TKI, dosage described in arm description.
Objective Remission Rate
Time frame: through study completion, an average of 15 months
Disease Control Rate
Time frame: through study completion, an average of 15 months
Progression free survival
Time frame: through study completion, an average of 15 months
Duration of Remission
Time frame: through study completion, an average of 15 months
Overall Survival
Time frame: through study completion, an average of 15 months
Time to Progression
Time frame: through study completion, an average of 15 months
Vital signs
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum alanine aminotransferase level
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum aspartate transaminase level
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum creatinine level
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum urea nitrogen level
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months
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Serum electrolytes level
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum brain natriuretic peptide (BNP) level
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months