Study Comparing Apatinib Mesylate to Standard Second-line TKIs for Advanced Gastrointestinal Stromal Tumors After First-line Treatment Failure

What this Trial Is About

This research aims to evaluate the effectiveness and safety of Apatinib Mesylate compared with standard second-line tyrosine kinase inhibitors TKIs in patients with advanced gastrointestinal stromal tumors GIST who have experienced failure with first-line TKI treatment. It also explores how the expression of VEGFR2 and microvessel density MVD relate to tumor characteristics such as location, size, mitotic count, and recurrence risk. The study is a randomized, open, controlled, single-center clinical trial involving patients with advanced GIST. Participants are randomly assigned in a 11 ratio to receive either Apatinib Mesylate, a new small molecule anti-angiogenic drug targeting VEGFR2, C-Kit, and PDGFR, or standard second-line TKI therapies such as Sunitinib, Imatinib, Dasatinib, or Reveratinib. The study focuses on comparing these two treatment groups to assess their outcomes. During the trial, participants are monitored for progression-free survival over 12 months, with additional evaluations of overall survival, objective response rate, and disease control rate over 24 months. Genetic testing involving blood samples and tumor tissue analysis is conducted when available. Safety and treatment response are closely observed, and participants are followed for at least two years to assess treatment impact and tumor control.

Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST