NCT07457775

Liposomal Irinotecan in Combination With Temozolomide and Bevacizumab in Patients With Advanced STS

A Study of Liposomal Irinotecan in Combination With Temozolomide and Bevacizumab in Patients With Relapsed or Refractory Soft Tissue Sarcoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The study is expected to include 24 patients with metastatic or surgically unresectable relapsed/refractory soft tissue sarcoma confirmed by histological evidence, who have received at least one line of systemic treatment previously. The efficacy and safety of liposome irinotecan combined with temozolomide and bevacizumab in the treatment of relapsed/refractory soft tissue sarcoma will be evaluated.

Conditions

• Soft Tissue Sarcoma (Excluding GIST)

Interventions

Type	Name	Description
DRUG	Irinotecan Hydrochloride Liposome Injection(II) combined with temozolomide and bevacizuma	Irinotecan Hydrochloride Liposome Injection(II) : 56.5 mg/m2, intravenous infusion for 90 minutes (+30 minutes), day 1, 3 weeks as one study cycle; Clotemozolomide: 100 mg/m2/day × 5 days, with 3 weeks as one study cycle; Bevacizumab: 7.5 mg/kg, intravenous infusion, 1 day, 3 weeks as one study cycle.

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-01-31
• Completion: 2028-01-31
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: China