NCT06110650

A Study of Surufatinib in the Treatment of Advanced Soft Tissue Sarcoma

A Single-arm, Single-center, Exploratory Phase II Study of Surufatinib in Patients With Soft Tissue Sarcoma Who Have Failed Anthracycline-containing Chemotherapy and Who Have Been Successfully Targeted With Antivascular Agents

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open, single-arm, phase II clinical study to investigate the efficacy and safety of patients with soft tissue sarcoma who have failed anthracycline-containing chemotherapy and whose antivascular agents have been effective and failed. Progression-free survival (PFS) was used as the primary outcome measure to preliminatively estimate the efficacy and safety of 29 patients with soft tissue sarcoma who had failed chemotherapy with anthracyclines and who had received effective and failed antivascular agents. Sofantinib 300mg orally, once a day, with continuous administration every 21 days, until the disease progresses or becomes intolerable; Imaging methods were used every 6 weeks (±7 days) after enrollment according to RECIST1.1 standard to evaluate the efficacy of tumor.

Conditions

• Soft Tissue Sarcoma Adult

Interventions

Type	Name	Description
DRUG	Surufatinib	Surufatinib 300mg orally, once a day, every 21 days for one cycle, treatment until disease progression or intolerance

Timeline

• Start date: 2023-11-28
• Primary completion: 2024-08-15
• Completion: 2025-08-15
• First posted: 2023-10-31
• Last updated: 2023-10-31