Soft Tissue Sarcoma Clinical Trial
Official title:
An Open-label, Multicenter, Phase II Study of Chiauranib Capsule in Patients With Advanced or Unresectable Soft Tissue Sarcoma Previously Failed to Standard of Care Treatment
The purpose of this trial is to explore the preliminary efficacy of Chiauranib monotherapy in patients with advanced or unresectable soft tissue sarcoma who failed standard therapy, and the safety of Chiauranib monotherapy in patients with advanced or unresectable soft tissue sarcoma who failed standard therapy and the relationship between potential biomarkers and preliminary efficacy.
Chiauranib has not yet been approved for marketing at home and abroad. It is a small-molecule anti-tumor targeted drug targeting multiple protein kinases. It has a three-way anti-tumor synergistic mechanism, including anti-tumor angiogenesis, inhibiting tumor cell mitosis, and regulating tumor inflammatory microenvironment, and exerts a comprehensive anti-tumor effect; at the same time, its high target selectivity also reduces the risk of Risk of side effects from off-target effects. Chiauranib has shown preliminary anti-tumor effects in multiple tumor types clinically, among which, two tumor types, small cell lung cancer and ovarian cancer, have entered phase III clinical studies. Drugs with similar mechanisms of action, pazopanib, regorafenib, anlotinib, apatinib (VEGFR, etc.) and Alisertib (targeting Aurora A, etc.) single-agents have demonstrated certain anti-tumor activity in STS patients , which provides a certain reference for Chiauranib. The trial used a single-arm, open-label, multicenter design to explore the preliminary efficacy and safety of Chiauranib in patients with advanced or unresectable soft tissue sarcoma who had failed standard therapy. If a subtype or several subtypes are found to have better efficacy, or if the biomarker study suggests a relationship with the initial efficacy, further research in specific subtypes will be considered after discussion between the investigator and the sponsor. The whole experimental study includes three phases: screening period, treatment period and follow-up period. ;
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