About this trial
To investigate the safety and efficacy of preoperative IMRT and concurrent Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Anlotinib Hydrochloride and Penpulimab for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age older than 18-yo
Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.
ECOG 0-3
Histology reviewed by reference pathologist
Disqualifiers
No gross tumor post-resection in other center.
Contraindications to Anlotinib, including allergic to Anlotinb, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.
Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.
Benign histology
Trial design
Single group
Treatments tested in this trial
Anlotinib hydrochloride
DrugAnlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT
Treatment groups
Trial outcomes
Primary outcomes
Major wound complications
Secondary outcomes
Acute and late toxicities
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Quality of Life
Evaluate quality of life by QOL questionnaires at different time points
Extremity function
Evaluate quality of life by MSTS forms at different time points
Pathological remission rate
evaluate the tumor remission rate microscopically
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Beijing Jishuitan Hospital
Collaborator