Efficacy and Safety of Radiotherapy Combined With Apatinib Mesylate in the Treatment of Rhabdomyosarcoma in Children
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of radiotherapy combined with apatinib mesylate in the treatment of rhabdomyosarcoma in children.
详细描述
This study is a Interventional study. The target group was 3-18 years old, and the pathological stage was group II-IV recurrence or distant metastasis. A total of 48 patients were enrolled in this study. The treatment was radiotherapy combined with apatinib. The main outcome measures were ORR, DCR , OS , quality of life and drug safety. The main safety indicators were vital signs, laboratory indicators, adverse events (AE), and severe adverse events (SAE). This study is expected to be enrolled for 6 months.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≥ 3 and ≤ 18 years of age.
- •The predicted survival period is more than 3 months.
- •According to RECIST version 1.1, there is at least one measurable lesion.
- •Postoperative pathological stage was group II-IV.
- •Patients have not received radiotherapy before, and can accept chemotherapy and surgical treatment.
- •No other anticancer therapy should be used during radiotherapy.
- •The main organs are functioning normally, which meets the following criteria:
- •Blood routine examination standards should be met: (no blood transfusion within 14 days) A.HB>90g/L; B.ANC>1.5*109/L; C.PLT>80*109/L
- •Biochemical tests should meet the following criteria:
- •A. BIL < 1.25 times normal upper limit (ULN); B. ALT and AST < 2.5 ULN; C. Serum Cr < 1 ULN, endogenous creatinine clearance > 50 ml/min
- •Subjects volunteered to participate in this study, patients or legal guardians signed informed consent through patient consent, good compliance, with follow-up.
- •Doctors believe that treatment can benefit patients.
排除标准
- 未提供
研究组 & 干预措施
Radiotherapy plus apatinib mesylate
All eligible patients signed informed consent. Three-dimensional conformal intensity modulation (IMRT) technique was used to treat the patients with radiation doses 45 Gy - 54 Gy. All patients took apatinib mesylate tablets 250 mg QD orally from 1 week before radiotherapy to the whole radiotherapy period. They were required to take apatinib mesylate tablets with warm boiling water half an hour after meal. The daily medication time should be as consistent as possible.
干预措施: Apatinib mesylate tablets (Drug)
Radiotherapy plus apatinib mesylate
All eligible patients signed informed consent. Three-dimensional conformal intensity modulation (IMRT) technique was used to treat the patients with radiation doses 45 Gy - 54 Gy. All patients took apatinib mesylate tablets 250 mg QD orally from 1 week before radiotherapy to the whole radiotherapy period. They were required to take apatinib mesylate tablets with warm boiling water half an hour after meal. The daily medication time should be as consistent as possible.
干预措施: Three-dimensional conformal intensity modulation (Radiation)
结局指标
主要结局
Objective response rate (ORR)
时间窗: First analysis will occur 1 month after accrual of all patients.
Refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained for a certain period of time, including CR and PR cases. Objective remission of solid tumors was assessed by RECIST 1.1. Subjects must be accompanied by measurable tumor lesions at baseline. According to RECIST 1.1, the criteria for evaluating efficacy are complete remission (CR), partial remission (PR), stability (SD), and progression (PD).
次要结局
- Incidence and severity of Adverse Events(From date of enrollment until 30 days after the last medication.)
- Quality of Life Score(Weekly assessment , assessed up to 1 month.)
- Disease Control Rate (DCR)(First analysis will occur 1 month after accrual of all patients.)
- Total Survival (OS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)