Phase II Study of Recombinant Endostatin Combined With Modified FOLFOX6 in Advanced Colorectal Cancer
Rh-Endostatin (Endostar; Simcere Pharmaceutical Co., Ltd, JiangSu,China) is a humanized
recombinant endostatin which is a direct angiogenesis inhibitor targeting the microvascular
endothelial cells (ECs). A pivotal phase III study completed in China demonstrated that the
addition of rh-endostatin to navelbine plus cisplatin conferred clinically significant
improvements in overall survival (OS), progression-free survival (PFS), as well as response
rate (RR), in patients with previously untreated metastatic non small cell lung cancer
(NSCLC). In vitro, the combination of Endostatin and fluorouracil showed synergistic
activity in inhibiting colon cancer. MFolfox6 was standard first-line regimen in advanced
colorectal cancer. The investigators carried out a phase II trial to investigate the
activity and safety of rh-endostatin plus mFOLFOX in patients with metastatic colorectal
cancer.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
response rate
From date of treatment was administered until the date of first documented response according to RECIST criteria
3 years
No
Lin Yang, MD
Principal Investigator
Cancer hospital&institute,Chinese Academy of Medical Sciences
China: Food and Drug Administration
CH-GI-023
NCT01529164
October 2011
March 2014
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