The aim of the study is to evaluate the safety and efficacy of apatinib mesylate tablets and chemotherapy drug Irinotecan in treatment of recurrent SCLC stage IIIB\&IV patients. It is a randomized controlled clinical trial.
Apatinib mesylate is a new inhibitor of VEGFR-2 tyrosine kinase targeting the intracellular ATPbinding site of the receptor. This research needs participants satisfied following criteria: 1. Aged between 18 and 70; 2. Locally advanced/metastatic small lung cancer (IIIB/IV) confirmed by pathology with measurable lesions; 3. Patients who was treated by platinum chemotherapy drugs(including sensitive recurrency and resistant recurrency) 4. ECOG:0-2; 5. the function of primary organs is normal. 6. Patients voluntarily entered the study and signed informed consent form (ICF). The primary goal of this research choose ORR, DCR and adverse effects as main curative effect criteria. PFS, OS and QoL as secondary curative effect criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Apatinib Mmesylate tablets 250mg/d, po, there's totally 4-6 cycles(21days per cycle)
Irinotecan 80mg/m2 d1, d8, vi, there's totally 4-6 cycles(21days per cycle)
duration of treatment
time from take apatinib to withdrawal from experiment due to adverse reaction of apatinib
Time frame: two years
progress free survival and overall survival
Secondary study endpoint
Time frame: two years
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