A phase I observational study on the safety and efficacy of treatment of recurrent stage IV high risk neuroblastoma with Nivolumab
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Sintilimab is administered every 21 days until the disease progresses or treatment is terminated due to unacceptable toxicity. For patients with clinical and radiologic benefits, treatment can last up to 2 years. Dose: 2 mg / kg intravenously for 60 min (± 10 min window)
Shanghai Children's Medical Center Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
response
Complete response: (CR): the tumor shrunk more than 50%. Part of the reaction: (PR): the reduction of tumor body was more than 30%. No response: (NP): the tumor decreased by less than 30% or increased.
Time frame: 2 years after taking the drug
side effect
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 2 years after taking the drug
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