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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 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-07-29

No results posted yet for this study

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

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；

Sponsors & Collaborators

  • Tang Xiaodong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07092306 on ClinicalTrials.gov