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

Recruiting now · Phase 2

Conditions studied: Sarcoma,Soft Tissue, Extremity, Trunk, Anlotinib, Intensity-modulated Radiotherapy, Major Wound Complications

In brief

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.

Key facts

Study ID

NCT05167994

Run by

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

People needed

30

Starts

2020-05-01

Expected to finish

2027-12-31

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Lesion can be assessed
• Can tolerate radiotherapy and Anlotinib
• Agree contraception.
• Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed

You may not qualify if…

• 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
• Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)
• STS can be cured by extensive operation alone.
• Previous irradiation to the same area
• Radiological evidence of distant metastases
• Other contraindications, can't tolerate operation or other treatment needed in this study.
• Neoadjuvant chemotherapy given or planned.

Where it is running

• Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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