The purpose of this study is to discuss the efficacy and safety of recombinant human endostatin(endostar) durative intravenous transfusion combined with pemetrexed plus cisplatin or carboplatin in the first-line treatment of advanced lung adenocarcinoma with wild-type EGFR or ALK-negative,compared with chemotherapy without endostar.
With the progress of molecular biology and translational medical research, the treatment of advanced non-small cell lung cancer goes into the era of personalized medicine. Lung adenocarcinoma accounts for about 50% of non-small cell lung cancer.In recent years, although individualized targeted therapy in lung adenocarcinoma progress by leaps and bounds, but the research of wild-type EGFR or ALK-negative lung adenocarcinoma is extremely lag, lack of clinically effective targeted drugs.As time goes on,almost all of the EGFR-TKI treatment of lung adenocarcinoma will be resistant one day,and patients need other treatments, such as chemotherapy.Currently, chemotherapy is still the main treatment for advanced lung adenocarcinoma with EGFR wild-type and unkown.Many researches has reported that:endostar combined with chemotherapy in patients with advanced NSCLC can significantly improve the patient's RR,TTP and did not increase the adverse effects of chemotherapy.Recently,endostar durative intravenous transfusion has been widely accept and use because of the lower toxicity.The purpose of our study was to discuss the efficacy and safety of endostard durative intravenous transfusion combined with chemotherapy.In our study,Patients with Ⅲb/Ⅳ lung adenocarcinoma were divided into two groups randomly,one group was treated with endostar durative intravenous transfusion combined with chemotherapy,while the other group with chemotherapy pemetrexed plus cisplatin or carboplatin only.In the end,PFS,ORR,DCR and OS were compared between these two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
endostar was continuous intravenous transfusion for 7 days,with the dose of 15mg/m2 for one day
the dose of pemetrexed was 500mg/m2 on day 1 of every 21 days,plus cisplatin or carboplatin.
Anhui provincial hospital
Hefei, Anhui, China
RECRUITINGprogression free survival
Time frame: Throughout the study period,an average of 1.5 year
objective response rate
Time frame: Throughout the study period,an average of 1.5 year
disease control rate
Time frame: Throughout the study period,an average of 1.5 year
overall survival
Time frame: after the study finished,an average of 2 year
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