NCT07092306

A Randomized Controlled Study Comparing the Safety and Efficacy of Irinotecan Hydrochloride Liposome Injection Combined With Temozolomide and Vincristine (NALIRI-VT) Versus Irinotecan Combined With Temozolomide and Vincristine (VIT) in Patients With Advanced Ewing's Sarcoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Tang Xiaodong · Academic / Other
• Sex: All
• Age: 8 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, controlled, multicenter, prospective clinical trial with a planned enrollment of 74 patients, who will be randomly assigned in a 2:1 ratio. After enrollment, patients will receive either irinotecan liposomal injection combined with temozolomide and vincristine or irinotecan injection combined with temozolomide and vincristine. The aim is to evaluate the efficacy, safety, and impact on quality of life of the irinotecan liposomal combination regimen compared to the irinotecan injection combined with temozolomide and vincristine in the treatment of advanced Ewing's sarcoma.

Conditions

• Ewing's Sarcoma

Interventions

Type	Name	Description
DRUG	Irinotecan Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT)	（NALIRI-VT，Nanoliposomal Irinotecan，Vincristine，Temozolomide）， Nanoliposomal Irinotecan：35 mg/m2/d，iv，D1，8，15， Temozolomide：100 mg/m2/d，po，D1-5， Vincristine：1.4 mg/m2/d，iv，D1，最大剂量2mg；
DRUG	Irinotecan Combined with Temozolomide and Vincristine (VIT)	（VIT，Vincristine，Irinotecan，Temozolomide） Irinotecan：50 mg/m2/d，iv，D1-5， Temozolomide：100 mg/m2/d，po，D1-5， Vincristine：1.4 mg/m2/d，iv，D1，最大剂量2mg；

Timeline

• Start date: 2025-08-10
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-07-29
• Last updated: 2025-07-29