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

Sponsor
Tang Xiaodong
Study ID
NCT07092306
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Ewing's Sarcoma

Eligibility Criteria

Sex
ALL
Age
8 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 10, 2025
Status verified
Jul 2025
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan Hydrochloride Liposome Injection Combined with Temozolomide and Vincristine (NALIRI-VT)
  • Active Comparator: Irinotecan Combined with Temozolomide and Vincristine (VIT)

Primary Outcome Measure

Objective Response Rate，ORR [ Time Frame: 6 weeks ]

Central Contacts

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