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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Evaluation of the Efficacy and Safety of Pazopanib in Combination with TGI/CIV for Recurrent or Refractory Rhabdomyosarcoma in Children or Adolescents (NCT06816771) is a Phase 2 interventional studying Rhabdomyosarcoma, Recurrent, Refractory, sponsored by Shandong Cancer Hospital and Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Rhabdomyosarcoma, Recurrent, Refractory and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 38 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Inclusion Criteria 1. diagnosed by tissue sample (biopsy-confirmed) rhabdomyosarcoma (RMS). 2. 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. First-line standard treatment can refer to the "Diagnosis and Treatment Guidelines for Rhabdomyosarcoma in Children and Adolescents (2019 Edition)". 3. Patients must have measurable lesions as per RECIST 1.1 criteria. 4. Age ≥ 2 years and ≤ 18 years, with no gender restrictions. 5. Karnofsky Performance Scale (KPS) score of 70-100% (\> 12 years) or Lansky Performance Scale score of 70-100% (≤ 12 years). 6. Expected survival time ≥ 12 weeks. 7. Before initiating any project-related procedures, the parents/guardians of the child or adolescent subjects must be able to understand, consent, and sign the willing to sign a consent form form (ICF) and applicable assent form; the subjects must be able to express consent with the consent of their parents/guardians (if applicable). 8. Adequate organ and bone marrow function, defined as follows: Bone marrow function: 1. Absolute neutrophil count (ANC) ≥ 1.5×109/L (≥ 0.5×109/L if bone marrow metastasis) 2. Platelet count ≥ 100×109/L (≥ 75×109/L if bone marrow metastasis) Hb ≥ 65 g/L (blood transfusion is allowed) 3. Hematopoietic growth factors: Treatment should be initiated at least 14 days after the last administration of long-acting growth factors or 1 day after the last administration of short-acting growth factors. renal function 1\) Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) 2) If serum creatinine \> 1.5 ULN, creatinine clearance rate \> 70 ml/min/1.73 m² Liver function ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria 1. Histologically or cytologically confirmed rhabdomyosarcoma (RMS). 2. 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. First-line standard treatment can refer to the "Diagnosis and Treatment Guidelines for Rhabdomyosarcoma in Children and Adolescents (2019 Edition)". 3. Patients must have measurable lesions as per RECIST 1.1 criteria. 4. Age ≥ 2 years and ≤ 18 years, with no gender restrictions. 5. Karnofsky Performance Scale (KPS) score of 70-100% (\> 12 years) or Lansky Performance Scale score of 70-100% (≤ 12 years). 6. Expected survival time ≥ 12 weeks. 7. Before initiating any project-related procedures, the parents/guardians of the child or adolescent subjects must be able to understand, consent, and sign the informed consent form (ICF) and applicable assent form; the subjects must be able to express consent with the consent of their parents/guardians (if applicable). 8. Adequate organ and bone marrow function, defined as follows: Bone marrow function: 1. Absolute neutrophil count (ANC) ≥ 1.5×109/L (≥ 0.5×109/L if bone marrow metastasis) 2. Platelet count ≥ 100×109/L (≥ 75×109/L if bone marrow metastasis) Hb ≥ 65 g/L (blood transfusion is allowed) 3. Hematopoietic growth factors: Treatment should be initiated at least 14 days after the last administration of long-acting growth factors or 1 day after the last administration of short-acting growth factors. renal function 1\) Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) 2) If serum creatinine \> 1.5 ULN, creatinine clearance rate \> 70 ml/min/1.73 m² Liver function 1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis) 2. Total bilirubin ≤ 1.5 times ULN Cardiac function 1\) Echocardiography LVEF ≥ 50%; 2) No severe cardiac rhythm or conduction abnormalities on electrocardiogram. Exclusion criteria: 1. 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. 2. 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. 3. Central nervous system metastasis. 4. A history of thrombosis within 3 months before enrollment and anticoagulation treatment for less than 6 weeks. 5. Known bleeding tendency, significant clinical bleeding symptoms within 3 months before treatment or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, vasculitis, etc.; or thrombotic events within 6 months before treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; or need long-term anticoagulation treatment with warfarin or heparin, or need long-term antiplatelet treatment (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day). 6. Uncontrolled hypertension and proteinuria in the recent period. And cannot be well controlled by antihypertensive drugs (infants \> 100/60 mmHg, preschool children (\< 6 years old) \> 110/70 mmHg, school-age children (6-12 years old) \> 120/80 mmHg, adolescents and adults \> 140/90 mmHg). 7. Use of antiepileptic drugs. 8. Long-term unhealed wounds, ulcers or fractures, major surgery within 28 days before enrollment or minor surgery within 7 days, abdominal fistula, gastrointestinal perforation. 9. Uncontrolled severe infection. 10. The presence of active heart disease within 6 months before treatment, including myocardial infarction, severe/unstable angina, etc. Poorly controlled arrhythmias with left ventricular ejection fraction \< 50% on echocardiography (including QTcF intervals \>450 ms in men and \>470 ms in women). 11. Any other malignancy was diagnosed within 3 years before treatment. 12. Known allergy to the study drug or any of its excipient. 13. Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B surface antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the assay). 14. According to the judgment of the researchers, patients with large tumors, easy to rupture and bleeding, and bleeding caused by tumor retraction are at high risk. 15. Concomitant medical conditions (e.g., poorly controlled hypertension, severe diabetes, neurological or psychiatric conditions, etc.) or any other condition that, in the investigator's judgment, could seriously endanger the safety of the subject, confound the study results, or interfere with the completion of the study.

Treatments Being Tested

DRUG

pazopanib

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.

DRUG

TGI chemotherapy

TGI chemotherapy (nab⁃Paclitaxel+ gemcitabine + ifosfamide)

DRUG

CIV chemotherapy

CIV chemotherapy (cyclophosphamide +Irinotecan + vinorelbine)

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

No. 440 Jiyan Road, Jinan City, Shandong Province
Jinan, Shandong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06816771), the sponsor (Shandong Cancer Hospital and Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06816771 clinical trial studying?

To evaluate the efficacy and safety of pazopanib combined with TGI/CIV chemotherapy in children and adolescents with recurrent or refractory rhabdomyosarcoma. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06816771?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06816771?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06816771. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06816771. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.