RecruitingPhase 2NCT06816771

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

Evaluation of Efficacy and Safety of Pazopanib Combined with TGI/CIV(nab⁃Paclitaxel+ Gemcitabine + Ifosfamide/cyclophosphamide +Irinotecan + Vinorelbine) in the Treatment for Children or Adolescents with Recurrent/refractory Rhabdomyosarcoma--an Open-label, Single-arm, Single-cente,phase II Clinical Trial


Sponsor

Shandong Cancer Hospital and Institute

Enrollment

38 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 2 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two anti-cancer drugs — pazopanib (a targeted therapy) and a metronomic chemotherapy regimen (TGI/CIV, meaning low-dose chemotherapy given frequently) — for children and adolescents with rhabdomyosarcoma (RMS), a rare cancer of the soft tissue, whose cancer has come back or stopped responding to treatment. **You may be eligible if...** - You are between 2 and 18 years old - You have a confirmed diagnosis of rhabdomyosarcoma - Your cancer has relapsed after complete remission, or it did not respond to at least four cycles of first-line chemotherapy - Your cancer is measurable on scans - Your physical performance status is adequate for treatment **You may NOT be eligible if...** - You have serious heart, liver, or kidney problems - You have uncontrolled high blood pressure - You have had certain recent surgeries or other anticancer therapies within required washout periods Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpazopanib

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.

DRUGTGI chemotherapy

TGI chemotherapy (nab⁃Paclitaxel+ gemcitabine + ifosfamide)

DRUGCIV chemotherapy

CIV chemotherapy (cyclophosphamide +Irinotecan + vinorelbine)


Locations(1)

No. 440 Jiyan Road, Jinan City, Shandong Province

Jinan, Shandong, China

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NCT06816771