Gastrointestinal Stromal Tumors Clinical Trial
Official title:
Efficacy and Safety of Anlotinib in Patients With Advanced Gastrointestinal Stromal Tumor After Failure of Imatinib: a Prospective, Single Arm and Multicenter Trial
Gastrointestinal stromal tumors (GIST) compose approximately 20% of soft tissue sarcomas with
an annual incidence of approximately 7 per million population. GISTs occur throughout the GI
tract, most commonly in the stomach or small intestine. The main treatment for localised GIST
is surgical resection. At least 40% of these patients will develop recurrence or metastasis
following complete resection. Local recurrence, liver metastases and/or dissemination within
the abdominal cavity are the most common clinical manifestations. Although imatinib and
sunitinib has greatly improved the quality of life and survival of patients with advanced
GIST. Analysis of clinical trials revealed that patients with tumours with KIT exon 17 or 18
mutations, with a second mutation in KIT exon 17 or 18, had worse responses to imatinib and
sunitinib. Some patients with PDGFRA D842V mutation do not respond to the present standard
therapies.
Anlotinib (1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yloxy)-6-methoxyquinolin-7-Yl] oxy]
methyl]cyclopropanamine dihydrochloride) , a multi-targeted tyrosine kinase inhibitor (TKI),
characterized as a highly selective and potent c-KIT, VEGFR, PDGFR, FGFR inhibitor. In vitro
and in vivo, Anlotinib has a broad spectrum of inhibitory action on tumor angiogenesis and
growth, which showed broad activity against soft tissue sarcoma and GIST with D842V, D816H,
V560G and V654A mutations. In 2015, the US FDA granted orphan drug treatment for ovarian
cancer.
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