drugset
drugset / Trial / 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

NCT07092306 ↗

Phase 2 Not yet recruiting 74 enrolled Tang Xiaodong
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-08-10
Primary completion
2027-05-01
Completion
2027-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 35 mg/m2 Intravenous
Subject Irinotecan Small molecule 50 mg/m2 Intravenous
Background Temozolomide Small molecule 100 mg/m2 Oral
Background Vincristine Small molecule 1.4 mg/m2 Intravenous

Indications

Ewing sarcoma