NCT04412408Unknown早期 1 期
Clinical Study on the Treatment of Recurrent Stage IV High Risk Neuroblastoma With Sintilimab
Shanghai Children's Medical Center1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- response
研究概览
简要总结
A phase I observational study on the safety and efficacy of treatment of recurrent stage IV high risk neuroblastoma with Nivolumab
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sintilimab
Experimental
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)
干预措施: Sintilimab (Drug)
结局指标
主要结局
response
时间窗: 2 years after taking the drug
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.
次要结局
- side effect(2 years after taking the drug)
研究者
研究点 (1)
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