Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP(gemcitabine+cisplatin) scheme for first-line advanced non small cell lung cancer and maintenance treatment.
Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP(gemcitabine+cisplatin) scheme for first-line advanced non small cell lung cancer and maintenance treatment. main objectives: PFS (progression-free survival) the secondary goal: ORR (overall response rate), DCR (disease control rate) and OS(overall survival)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Endostar,30mg continuous intravenous injection pump, d1-d7,21 days as one cycle, 4 cycles in total
Gemcitabine,1000mg/m2, i.v, d1 and d8 in each cycle, 21 days as one cycle, 4 cycles in total
Cisplatin,75mg/m2, i.v, d1 in each cycle, 21 days as one cycle, 4 cycles in total
Progression-free Survival (PFS)
PFS is a tumor progression or death time of a patient who has an objective record on the date of enrollment. PFS calculation end if the patient was lost, unknown death , or other anti tumor therapy was used.
Time frame: Time Frame: up to month 36
ORR
overall remission rate
Time frame: Time Frame: change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
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