Clinical Trial: Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Recombinant Human Endostatin Durative Transfusion Combined With Pemetrexed Plus Cisplatin or Carboplatin in the First-line Treatment of Advanced Lung Adenocarcinoma With W

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Anhui Provincial Hospital

Current Primary Outcome: progression free survival [ Time Frame: Throughout the study period，an average of 1.5 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Anhui Provincial Hospital

Dates:
Date Received: June 15, 2016
Date Started: June 2016
Date Completion: December 2018
Last Updated: June 19, 2016
Last Verified: June 2016