Phase Ii Study Of Anlotinib For Treatment Of Advanced Soft Tissues Sarcomas.

11005Background: No standard therapies are available in China for Soft tissues sarcomas (STS)patients who failed to chemotherapies. Anlotinib is a multi-target RTK inhibitor, with VEGFR1/2/3, FGFR1/2/3, PDGFRα/β, c-Kit, Ret ect. Recommended dose in phase I is 12 mg daily, 2 weeks on/1 week off. This single-arm, multi-center phase II study (NCT01878448) to assess efficacy and safety of Anlotinib for treatment of STS patients who failed to conventional therapies. Methods: Pathological types of advanced STS mainly include malignant fibrous histiocytoma (MFH), liposarcoma, leiomyosarcoma, synovial sarcoma (SS) and other sarcomas, but excluding RMS, chondrosarcoma, GIST etc. Patients with measurable indicators (RECIST1.1) were treated with Anlotinib. Efficacy was assessed every 6 weeks. The primary endpoint was disease PFR at week 12 (PFR12w ). Results: From April 2013, we recruited 166 patients in 15 centers in China, including 100 males and 66 females, average age is 44 (15-70). Pathological types included S...