Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.

Sponsor
Yizhuo Zhang
Study ID
NCT06514313
Phase
PHASE2
Status
Recruiting
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Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
2 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Explore the efficacy and safety of mitoxantrone liposome combined with irinotecan and vincristine (VIM) in the treatment of relapsed/refractory soft tissue sarcoma in children.

Key Dates

Start date
Jul 3, 2024
Status verified
Jul 2024
Primary completion
Aug 1, 2026
Completion
Dec 1, 2026

Study Design

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

Arms

  • Experimental: VIM
    Mitoxantrone Hydrochloride Liposome combined with Irinotecan and Vincristine.
  • Active Comparator: VIT
    Temozolomide combined with Irinotecan and Vincristine.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 2 cycles of chemotherapy (each cycle is 21 days) ]

Central Contacts

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