Study of Anlotinib Combined With Doxorubicin and Radiotherapy Before Surgery for Soft Tissue Sarcoma

What this Trial Is About

Researchers are studying the safety and effectiveness of combining anlotinib with doxorubicin monotherapy and radiotherapy as a pre-surgery treatment for soft tissue sarcoma. This prospective, open-label, single-arm study focuses on patients with high-grade soft tissue sarcoma who are eligible for surgery and chemotherapy. The goal is to explore how this combined approach works before and after surgery. The treatment plan includes three cycles of neoadjuvant chemotherapy with doxorubicin given intravenously on days 1 and 2 every three weeks, alongside daily anlotinib for 14 days each cycle. After the second chemotherapy cycle, patients receive stereotactic body radiation therapy with a total dose of 40 Gy before surgery, which occurs in the ninth week following the third chemotherapy cycle. Post-surgery, patients continue with three additional cycles of chemotherapy, making six cycles in total. Participants will undergo regular assessments including pathological response evaluations at three months to measure major and complete responses. Researchers will also monitor objective tumor response and disease-free survival over two years. Safety and treatment adherence are tracked throughout the study. The total participation period includes chemotherapy cycles, radiotherapy, surgery, and follow-up assessments extending up to two years after treatment begins.

Anlotinib Combined With Doxorubicin and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma