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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

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

Qualifiers

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

Treatments tested in this trial

  • Anlotinib hydrochloride

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators