Actively Recruiting
Evaluation of the Efficacy and Safety of Pazopanib in Combination with TGI/CIV for Recurrent or Refractory Rhabdomyosarcoma in Children or Adolescents
Led by Shandong Cancer Hospital and Institute · Updated on 2025-02-10
38
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of pazopanib combined with TGI/CIV chemotherapy in children and adolescents with recurrent or refractory rhabdomyosarcoma.
CONDITIONS
Official Title
Evaluation of the Efficacy and Safety of Pazopanib in Combination with TGI/CIV for Recurrent or Refractory Rhabdomyosarcoma in Children or Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed rhabdomyosarcoma by tissue or cell testing.
- Diagnosis of recurrent or refractory rhabdomyosarcoma based on clinical criteria.
- Measurable tumors according to standard response criteria.
- Age between 2 and 18 years, any gender.
- Karnofsky Performance Scale score 70-100% for those older than 12 years, or Lansky Performance Scale score 70-100% for 12 years or younger.
- Expected survival time of at least 12 weeks.
- Parents or guardians able to understand and sign consent forms; participants able to provide assent if applicable.
- Adequate bone marrow function, including specific blood count thresholds.
- Adequate kidney function with serum creatinine below 1.5 times the normal limit or sufficient creatinine clearance.
- Adequate liver function with certain enzyme and bilirubin limits.
- Adequate heart function with left ventricular ejection fraction at or above 50% and no severe heart rhythm problems.
You will not qualify if you...
- Received radiotherapy, chemotherapy, targeted therapy, investigational drugs, or live vaccines within 2 weeks before treatment.
- Used anti-angiogenic drugs like pazopanib or similar within the past 3 months.
- Presence of metastasis in the central nervous system.
- History of thrombosis or certain bleeding conditions within recent months.
- Uncontrolled high blood pressure or proteinuria not managed by medication.
- Use of antiepileptic drugs.
- Recent major or minor surgeries, unhealed wounds, ulcers, or fractures.
- Uncontrolled severe infections.
- Active heart disease within 6 months before treatment.
- Any other cancer diagnosed within 3 years before treatment.
- Known allergy to the study drug or its ingredients.
- Infection with HIV or active hepatitis B or C.
- Large tumors at high risk of bleeding as judged by researchers.
- Other serious medical conditions that could affect safety or study completion as judged by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
No. 440 Jiyan Road, Jinan City, Shandong Province
Jinan, Shandong, China, China,250117
Actively Recruiting
Research Team
S
Shuai Man, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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