Anlotinib Hydrochloride Capsules in Maintenance Treatment for Intermediate-High Risk Rhabdomyosarcoma in Children

Sponsor
Sun Yat-sen University
Study ID
NCT07137884
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Maintenance Treatment
  • Rhabdomyosarcoma Recurrent

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Anlotinib+Cyclophosphamide+Vinorelbine — DRUG
    Anlotinib hydrochloride capsules combined with Cyclophosphamide+Vinorelbine), Anlotinib hydrochloride capsules 8mg (weight ≤35kg) or 12mg (weight \> 35kg), po, qd, D1-D14;on an empty stomach ,Two weeks off for one week，with a cycle of 3 weeks. Cyclophosphamide 25mg/m2, po, qd, D1-D28, with a cycle of 4 weeks. vinorelbine 60g/m2, po, qw, D1, 8,15, with a cycle of 4 weeks.
  • Cyclophosphamide+Vinorelbine — DRUG
    Cyclophosphamide 25mg/m2, po, qd, D1-D28, with a cycle of 4 weeks. vinorelbine 60mg/m2, po, qw, D1, 8,15, with a cycle of 4 weeks.

Study Details

This is a randomized controlled phase II clinical study aimed at evaluating the efficacy and safety of anlotinib hydrochloride in children with Intermediate-High -risk rhabdomyosarcoma. The study enrolled children with rhabdomyosarcoma confirmed by histopathology, with a clinical risk classification of high or Intermediate-risk accompanied by high-risk factors (high-risk factors are defined as age \> 10 years，Poor prognosis molecular characteristics or those who cannot undergo surgery/radiotherapy);One year of maintenance treatment with anlotinib can increase the duration of response and long-term survival.

Key Dates

Start date
Oct 1, 2025
Status verified
Jul 2025
Primary completion
Oct 30, 2028
Completion
Dec 30, 2028

Study Design

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

Arms

  • Experimental: Combination medication group
  • Active Comparator: Conventional maintenance treatment

Primary Outcome Measure

DOR (Duration of Response) [ Time Frame: 2 year ]

Central Contacts