Efficacy and Safety of Induction Chemotherapy for Olfactory Neuroblastoma: a Prospective Umbrella Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Objective remission rate(ORR)
研究概览
简要总结
The goal of this clinical trial is to learn about the induction chemotherapy efficacy in olfactory neuroblastoma. The main question it aims to answer is: wether olfactory neuroblastoma patients with different pathology subtypes apply to different induction chemotherapy schemes. Participants will be treated with different chemotherapy schemes, to evaluate the tumor remission rate and long term survival.
详细描述
This study included patients with olfactory neuroblastoma who were pathologically diagnosed and met the criteria. According to molecular profiles, two different induction chemotherapy schemes were used to evaluate the tumor remission rate.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically confirmed olfactory neuroblastoma;
- •Age ≥ 18 years old;
- •Dulguerov stage T2-T4;
- •Patients who signed the informed consent forms;
- •No distant metastasis.
排除标准
- •Patients with uncontrolled concurrent diseases that the researchers believe will interfere with treatment;
- •Any situation in which the patient may interfere with the compliance or safety during the study;
- •Severe neurological or mental illness, including dementia and seizures;
- •Uncontrolled active infection;
- •Pregnant or lactating women;
- •Persons without personal freedom and independent capacity for civil conduct;
- •Other situations that are not suitable for joining the group.
研究组 & 干预措施
Induction chemotherapy in different subtypes of olfactory neuroblastoma
Induction chemotherapy based on pathological molecular subtypes of olfactory neuroblastoma.
① According to the immunohistochemical results of the pathological report, patients with Ki-67 index ≥ 25% were treated with two weeks of gemcitabine+platinum based chemotherapy regimen;
② According to the immunohistochemical results of the pathological report, patients with Ki-67 index <25% were treated with a basic chemotherapy regimen of cyclophosphamide+etoposide+cisplatin (CEP regimen);
According to the progression of the patient's disease, the combination of other chemotherapy/small molecule drugs/targeted drugs can be considered;
干预措施: Gemcitabine+Cisplatin(GP); Cyclophosphamide+Etoposide+Cisplatin(CEP) (Drug)
结局指标
主要结局
Objective remission rate(ORR)
时间窗: 3 to 12 weeks after completion of induction chemotherapy
According to RECIST1.1 criteria, complete remission (CR) and partial remission (PR)
次要结局
- Rate of treatment related side effects(2 years (24 months))
- 2-year overall survival (OS) rate(2 years (24 months))
- Pathological complete remission(pCR) rate after induction chemotherapy.(about 4 weeks after surgical resection, up to 12 weeks)
- The rate of surgical pathology negative margin(about 4 weeks after surgical resection, up to 12 weeks)
研究者
Hongmeng Yu
Professor
Eye & ENT Hospital of Fudan University