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Brief Title: Efficacy and Safety of Anlotinib in Patients With Advanced Gastrointestinal Stromal Tumor After Failure of Imatinib: a Prospective, Single Arm and Multicenter 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
Study ID: NCT04106024
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Cancer Hospital, Beijing, Beijing, China
Name: Xin Wu
Affiliation: Chinese PLA General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Xinhua Zhang
Affiliation: First Affiliated Hospital, Sun Yat-Sen University
Role: PRINCIPAL_INVESTIGATOR
Name: Ye Zhou
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
Name: Bo Zhang
Affiliation: West China Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: XiaoFeng Sun
Affiliation: Jiangsu Cancer Institute & Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: HongYan Qu
Affiliation: Harbin Medical University
Role: PRINCIPAL_INVESTIGATOR