Preoperative Radiotherapy Combined With Anlotinib Hydrochloride and Penpulimab for Localized Soft Tissue Sarcoma of the Trunk or Extremities

What this Trial Is About

Researchers are studying the safety and effectiveness of preoperative intensity-modulated radiotherapy IMRT combined with the drugs Anlotinib Hydrochloride and Penpulimab in adults with primary soft tissue sarcoma located in the trunk or extremities. This phase 2 trial also aims to assess quality of life, limb function after treatment, the mechanism by which these drugs may make cancer cells more sensitive to radiation, and how MRI and pathology findings relate to local tumor control. Participants will receive preoperative IMRT along with daily Anlotinib 12 mg starting from the first day of radiotherapy until one month after completing IMRT. Penpulimab is also given concurrently and sequentially with this combination. This treatment plan is designed for people with localized sarcoma suitable for conservative surgery after radiotherapy. During the study, participants will be monitored for major wound complications four months after surgery, as well as acute and late side effects of treatment. Quality of life and limb function will be evaluated before, during, and after radiotherapy and at regular follow-up visits. Researchers will also assess pathological remission two weeks post-operation, local tumor control, and overall survival at two years. The total participation duration varies based on follow-up schedules.

Preoperative IMRT With Anlotinib and Penpulimab for Localized Sarcoma （SPARE-01）