Actively Recruiting
Apatinib Mesylate Combined With IT Regimen for the Treatment of Recurrent or Refractory Pediatric Neuroblastoma: A Single-arm, Phase I/II，Multi-center, Clinical Study.
Led by Sun Yat-sen University · Updated on 2026-02-05
125
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The survival rate of recurrent and refractory pediatric neuroblastoma is low and the prognosis is poor. Apatinib mesylate is a highly selective small-molecule vasoendothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor. Apatinib mesylate has been shown to be safe and effective in recurrent or refractory pediatric neuroblastoma in Sun Yat-sen University Cancer Center. Apatinib mesylate combined with IT regimen is expected to further improve the efficacy and survival rate of recurrent or refractory pediatric neuroblastoma.
CONDITIONS
Official Title
Apatinib Mesylate Combined With IT Regimen for the Treatment of Recurrent or Refractory Pediatric Neuroblastoma: A Single-arm, Phase I/II，Multi-center, Clinical Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 5 and 18 years old, any gender
- ECOG performance status score of 0 to 1
- Expected survival longer than 12 weeks
- Neuroblastoma diagnosis confirmed by tissue pathology
- Disease progressed, recurred, or refractory after first-line treatment
- Measurable tumor lesions meeting specific size criteria by CT scan
- Fully recovered from acute toxic effects of prior chemotherapy
- At least 21 days since last myelosuppressive chemotherapy (42 days if nitrosourea used)
- No other experimental drugs or anticancer therapies within 28 days before starting study treatment
- Time intervals since last hematopoietic growth factors, immunotherapy, and radiation therapy as specified
- No active graft-versus-host disease after stem cell infusion; at least 56 days post-transplant
- Laboratory results within specified normal limits during screening
- Ability to comply with outpatient treatment, monitoring, and clinical visits
- Parent or guardian able to understand and sign informed consent; patients able to provide assent if applicable
You will not qualify if you...
- Symptomatic brain metastases (unless treated and stable for at least 21 days)
- Tumor located 5 mm or less from large blood vessels or invading large vessels
- Use of two or more antihypertensive drugs for hypertension
- Certain cardiovascular diseases including myocardial ischemia, poorly controlled arrhythmia, severe heart failure, or low heart function
- History or presence of interstitial lung disease
- Abnormal blood clotting, bleeding tendencies, or current anticoagulant therapy
- Significant bleeding events within 3 months before enrollment
- Recent arterial or venous thrombosis within 12 months
- Known bleeding or clotting disorders
- Unhealed wounds or fractures
- Major surgery or severe trauma within 4 weeks before enrollment
- Conditions affecting oral drug absorption like inability to swallow or chronic diarrhea
- Recent abdominal fistula, perforation, or abscess within 6 months
- Significant proteinuria in urine tests
- Active infections needing antimicrobial treatment
- History of psychotropic drug abuse or mental disorders
- Participation in other antitumor drug trials within 4 weeks
- Other untreated malignant tumors except certain skin, cervical, or bladder cancers
- Use of strong CYP3A4 inhibitors or inducers within specified days before treatment
- Pregnancy, breastfeeding, or unwillingness/inability to use effective contraception
- Positive tests for hepatitis B, hepatitis C, or HIV infection
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yizhuo Zhang
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Y
Yizhuo Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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