NCT05941325

A Single-arm, Open-label, Single-center Prospective Study of Fruquintinib Combined With Envafolimab in the Treatment of Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma

Shanghai Sixth People's Hospital

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai 6th People's Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Many osteosarcomas are cured with a variety of combined chemotherapy and surgery, but a significant number will still relapse.VEGF promotes an immunosuppressive microenvironment and contributes to immune checkpoint inhibitor resistance in cancer.We aimed to explore the efficacy and safety of fruquintinib combined immunotherapy for bone and soft tissue sarcoma.

Detailed description

A single-arm, open-label, single-center prospective study of fruquintinib combined with envafolimab in the treatment of advanced or unresectable locally advanced bone and soft tissue sarcoma.

Conditions

• Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	fruquintinib	VEGF receptor tyrosine-kinase inhibitor：fruquintinib（4mg), Oral，qd, d1-d14, Q3w，Until disease progression or intolerable toxicity occurs.
DRUG	Envafolimab	anti-PD-1 immune checkpoint inhibitor：Envafolimab（400mg), subcutaneous injection, d1, Q3w，Until disease progression or intolerable toxicity occurs.

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2023-07-12
• Last updated: 2025-05-18

Locations

1 site across 1 country: China