Study on Sintilimab in Stage IV High Risk Neuroblastoma

Study Overview
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Brief Summary
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A phase I observational study on the safety and efficacy of treatment of recurrent stage IV high risk neuroblastoma with Nivolumab

Official Title
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Clinical Study on the Treatment of Recurrent Stage IV High Risk Neuroblastoma With Sintilimab

Conditions
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Recurrent Stage IV High Risk Neuroblastoma

Intervention / Treatment
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* Drug: Sintilimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12 Months to 12 years Histologic verification of stage IV high risk neuroblastoma at relapse following lack of complete response to at least two lines of therapy Fully recovered from the acute toxic effects of all prior anti-cancer treatment At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea) At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines At least 56 days must have elapsed after transplant or stem cell infusion; patients with prior allogeneic transplants are not eligible Blood counts recovery including White cell count >= 750/mm^3 and Platelet count >= 50,000/mm^3 Creatinine clearance ≥ 50ml/min Liver function: Total bilirubin ≤ 2 mg/dl, Alanine aminotransferase or Aspartate aminotransferase ≤ 2.5 U/dl (or < 5 in case of liver impairment) Life expectancy of at least 4 months Negative pregnancy test in women of childbearing potential Use of an effective contraceptive method during the whole treatment and up to 3 months after the completion of treatment in males and females Prior informed consent signed Exclusion Criteria: Patients requiring daily systemic corticosteroids are not eligible; patients must not have received systemic corticosteroids within 7 days of enrollment on study Patients who are currently receiving another investigational drug are not eligible Patients who are currently receiving other anti-cancer agents are not eligible Patients with a history of any grade autoimmune disorder are not eligible; asymptomatic laboratory abnormalities (e.g. antinuclear antibody (ANA), rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder Patients with >= grade 2 hypothyroidism due to history of autoimmunity are not eligible; note: hypothyroidism due to previous irradiation on thyroidectomy will not impact eligibility Patients who have an uncontrolled infection are not eligible. Patients with active autoimmune disease. (any autoimmune state requiring medical treatment-including chronic medications)all immune modifying drugs should be stopped at least 7 days prior to enrollment

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sintilimab<br>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) | Drug: Sintilimab<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years after taking the drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effect | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 2 years after taking the drug |