Study Design
Cancer
DISEASE, SECONDARY, GIST, CANCER
This study was a multi-center, single-arm, phase II study to evaluate the efficacy of anlotinib for patients with metastatic GIST after imatinib failure. The primary endpoint was to assess median progression-free survival (PFS) of anlotinib therapy. The secondary endpoints included assessment of overall response rate (ORR), disease control rate (DCR), overall survival (OS), and safety of anlotinib. The DCR was defined as CR + PR + SD, and the RECIST standard is at least 4 weeks. The study also compared the data of this anlotinib trial with second-line sunitinib treatment in patients with metastatic GIST in the real world during the study period.All procedures performed in this study involving human participants were approved by Beijing Cancer Hospital Ethical Committee. Written informed consent was obtained from the patients before study entry. The study was conducted according to the ethical principles of the Declaration of Helsinki. The clinical trial registration number is NCT04106024.