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

ConditionRhabdomyosarcoma, Recurrent, Refractory
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • pazopanib

    Drug

    Given PO The dosage will be determined according to the participant's body surface area, with body surface area less than 0.75, 1 tablet, and 2 tablets for body surface area greater than 1. 0.75-1,1.5 tablets.

  • TGI chemotherapy

    Drug

    TGI chemotherapy (nab⁃Paclitaxel+ gemcitabine + ifosfamide)

  • CIV chemotherapy

    Drug

    CIV chemotherapy (cyclophosphamide +Irinotecan + vinorelbine)

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate(ORR)

Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1

Time frame
Up to 4 cycles of chemotherapy (each cycle is 21 days)

Secondary outcomes

1

Disease control rate (DCR)

Refers to the percentage of patients with confirmed complete response, partial response, and disease stability in patients with evaluable efficacy

Time frame
Up to 4 cycles of chemotherapy (each cycle is 21 days)
2

Incidence of adverse events

Use NCI-CTCAE version 5.0 for classification and grading

Time frame
Up to 4 cycles of chemotherapy (each cycle is 21 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Cancer Hospital and Institute

Lead sponsor

Source ClinicalTrials.gov
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