Evaluation of the Efficacy and Safety of Pazopanib in Combination with TGI/CIV for Recurrent or Refractory Rhabdomyosarcoma in Children or Adolescents

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-18
SponsorShandong Cancer Hospital and Institute

About this trial

To evaluate the efficacy and safety of pazopanib combined with TGI/CIV chemotherapy in children and adolescents with recurrent or refractory rhabdomyosarcoma.

Eligibility criteria

Qualifiers

Histologically or cytologically confirmed rhabdomyosarcoma (RMS).

Patients diagnosed with recurrent/refractory RMS based on clinical diagnostic criteria. Recurrence is defined as disease recurrence confirmed after achieving complete remission and completing at least one line of standard treatment; refractory is defined as disease progression as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) after at least four cycles of first-line chemotherapy.

Patients must have measurable lesions as per RECIST 1.1 criteria.

Age ≥ 2 years and ≤ 18 years, with no gender restrictions.

Disqualifiers

Received any of the following treatments within 2 weeks before treatment: radiotherapy, chemotherapy, or molecular targeted therapy for tumors; other investigational drugs; or live attenuated vaccines.

Patients who have received anti-angiogenic targeted drugs such as apatinib, pazopanib, sunitinib, sorafenib, bevacizumab, imatinib, crizotinib, famitinib, anlotinib, regorafenib, endostatin, etc. within the past 3 months.

Central nervous system metastasis.

A history of thrombosis within 3 months before enrollment and anticoagulation treatment for less than 6 weeks.

Trial design

Treatments tested in this trial

  • pazopanib
  • TGI chemotherapy
  • CIV chemotherapy

Treatment groups

38 Participants
are divided into 1 treatment group