A Multicenter Phase II Clinical Study of Albumin-bound Paclitaxel (Nab-PTX), Ifosfamide and Cisplatin in the Treatment of Pediatric Advanced, Recurrent or Refractory Extracranial Germ Cell Tumor.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 43
- 主要终点
- overall response rate，ORR
研究概览
简要总结
The purpose is to evaluate the effectiveness and safety of albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin in the treatment of children patients with advanced, recurrent or refractory extracranial germ cell tumor.
详细描述
Children patients with advanced, recurrent or refractory extracranial germ cell tumor were treated with albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin . This is a multi-center and single arm phase II clinical study.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 1-18 years old;
- •ECOG PS score: 0-1;
- •Patients was confirmed pathologically with malignant germ cell tumor.
- •Patients with tumor progressed, relapsed or refractory after first-line chemotherapy, and complete or partial remission was not achieved after recent treatment.
- •Have at least one measurable lesion defined by RECIST standard;
- •The estimated survival time was more than 6 months;
- •Patients must fully recover from the acute toxicity of previous anticancer chemotherapy:
- •Bone marrow function met the following criteria:
- •Absolute neutrophil count (ANC) ≥ 1.0 × 109 / L;
- •Platelet count ≥ 100.0 × 109 / L (not after platelet transfusion);
- •Liver and kidney function should meet the following criteria:
- •Bilirubin (the sum of bound and unconjugated) ≤ 1.5 × upper limit of normal value (ULN) (corresponding to age). Patients with confirmed Gilbert's syndrome can be classified according to the researcher;
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
- •Estimated glomerular filtration rate ≥ 70 ml / min / 1.73 m2 or normal serum creatinine (CR);
- •Adequate pulmonary function: no dyspnea at rest, no exercise intolerance, pulse oxygen saturation > 94% (if there are clinical symptoms);
- •Cardiac function:
- •LVEF ≥ 50% was detected by echocardiography;
- •There was no history of arrhythmia requiring drug intervention before enrollment;
- •Seizures that can be fully controlled without enzyme-induced anticonvulsants;
- •During the study period, they were able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
- •Parents / guardians of child or adolescent subjects have the ability to understand, agree and sign the study informed consent form (ICF) and the applicable child consent form before starting any program related procedures; subject has the ability to express consent (when applicable) with the consent of parents / guardians.
排除标准
- •Patients with any of the following items will not be enrolled in this study:
- •Patients with recurrent germ cell tumor were treated by surgery alone previously;
- •Patients with immature teratoma (any grade);
- •Patients with sex cord stroma;
- •HBsAg positive patients;
- •Patients with HIV or syphilis infection;
- •Patients who had received organ transplantation before;
- •Uncontrolled active systemic bacterial, viral or fungal infections;
研究组 & 干预措施
nab-PTX, ifosfamide and cisplatin
albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin in the treatment of pediatric advanced, recurrent or refractory extracranial germ cell tumor.
干预措施: albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin (Drug)
结局指标
主要结局
overall response rate，ORR
时间窗: From the beginning of observation to the 2 cycles of observation(each cycle is 21 days)
Percentage of participants who experienced an overall response (overall response rate，ORR) of albumin-binding paclitaxel, ifosfamide, cisplatin regimen in the treatment of advanced, recurrent and refractory children with extracranial germ cell tumor.
次要结局
未报告次要终点
研究者
Yizhuo Zhang
Director of department of pediatric cancer,Principal Investigator,Clinical Professor
Sun Yat-sen University