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OncoMatch/Clinical Trials/NCT06816771

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

Is NCT06816771 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including pazopanib and TGI chemotherapy for rhabdomyosarcoma, recurrent, refractory.

Phase 2RecruitingShandong Cancer Hospital and InstituteNCT06816771Data as of May 2026

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

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Extracted eligibility criteria

Cancer type

Rhabdomyosarcoma

Performance status

KARNOFSKY/LANSKY 70–100

Karnofsky Performance Scale (KPS) score of 70-100% (> 12 years) or Lansky Performance Scale score of 70-100% (≤ 12 years)

Prior therapy

Min 1 prior line

Must have received: standard chemotherapy — first-line

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

Cannot have received: anti-angiogenic targeted therapy (apatinib, pazopanib, sunitinib, sorafenib, bevacizumab, imatinib, crizotinib, famitinib, anlotinib, regorafenib, endostatin)

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

Cannot have received: radiotherapy

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

Cannot have received: chemotherapy

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

Cannot have received: molecular targeted therapy

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

Cannot have received: investigational drug

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

Lab requirements

Blood counts

ANC ≥ 1.5×10⁹/L (≥ 0.5×10⁹/L if bone marrow metastasis); platelets ≥ 100×10⁹/L (≥ 75×10⁹/L if bone marrow metastasis); Hb ≥ 65 g/L (blood transfusion allowed)

Kidney function

Serum creatinine ≤ 1.5 × ULN; if > 1.5 × ULN, creatinine clearance rate > 70 ml/min/1.73 m²

Liver function

ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis); total bilirubin ≤ 1.5 × ULN

Cardiac function

Echocardiography LVEF ≥ 50%; no severe cardiac rhythm or conduction abnormalities on ECG

Adequate organ and bone marrow function, defined as follows: ... (see full criteria for details)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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