A new study that aims to compare the safety and efficacy of apatinib mesylate to standard second-line tyrosine kinase inhibitor therapy in patients with advanced gastrointestinal stromal tumors (GIST) is now recruiting participants in China. 

The randomized, open-label, controlled, single-center clinical study aims to recruit 258 patients with GIST, 18 years of age and over, who were previously treated with imatinib or avatinib, but whose disease progressed or who developed toxicity intolerance during treatment.

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Participants will randomly be divided into 2 groups and either receive apatinib mesylate or standard second-line therapy such as sunitinib or imatinib plus dasatinib and reveratinib.

The primary outcome measure of the study is progression-free survival. Secondary outcome measures are overall survival, objective response rate, and disease control rate. 

The study sponsored by Xiangya Hospital of Central South University in China started on February 1, 2023, and is estimated to be completed on January 1, 2027.

Patients who were previously treated with molecularly targeted therapies other than imatinib or avatinib are not eligible to take part in the study. 

GISTs are a rare type of soft-tissue tumor developing from the interstitial cells of Cajalf, which are situated in the wall of the gastrointestinal tract. The first-line treatment for localized tumors is surgical excision, but around 10% of tumors recur after surgery. Unresectable and recurrent tumors are treated with tyrosine kinase inhibitors. The first option is usually imatinib mesylate. If patients do not respond to imatinib, they may be treated with second-line therapy.

Apatinib mesylate is a new type of oral antiangiogenic agent. It is a small molecule tyrosine kinase inhibitor against vascular endothelial growth factor receptor 2. It works by inhibiting endothelial cell migration and proliferation, thereby blocking the formation of new blood vessels in tumor tissue.


Apatinib mesylate versus standard second-line TKI in the treatment of advanced GIST. US National Library of Medicine. Last updated March 2, 2023. Accessed March 14, 2023.