Doxorubicin Hydrochloride Liposome Combined With Irinotecan (AI Regimen) Versus VIT Regimen in the Treatment of Relapsed and Refractory Pediatric Rhabdomyosarcoma: a Prospective, Open-label, Randomized Controlled, Multicenter, Phase II Clinical Study

Sponsor
Sun Yat-sen University
Study ID
NCT05457829
Phase
PHASE2
Status
Recruiting
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Conditions

  • Rhabdomyosarcoma, Child

Eligibility Criteria

Sex
ALL
Age
6 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This multicenter, randomized, controlled, open-label, prospective clinical trial was designed to evaluate the efficacy and safety of doxorubicin hydrochloride liposome injection in combination with irinotican (AI regimen) versus VIT regimen in the treatment of relapsed and refractory pediatric rhabdomyosarcoma.

Key Dates

Start date
Dec 30, 2023
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

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

Arms

  • Experimental: AI Regimen
    Doxorubicin hydrochloride liposome injection combined with Irinotecan
  • Active Comparator: VIT Regimen
    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