NCT03300765Unknown2 期
Intensity Modulated Radiation Therapy Combined With Apatinib for Inoperable or Iodine Refractory Thyroid Cancer: A Phase II Single-arm Study
Xiayun He, MD1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
To determine the efficacy and safety of intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand character and individual consequences of the clinical trial. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;
- •Aged ≥ 18 years old;
- •Pathologically confirmed inoperable or iodine refractory thyroid cancer, or postoperative residual disease detected by imaging studies, or progression disease within 12 months before enrollment. (all with measurable disease ≥10mm according to RECIST 1.1);
- •Adequate laboratory values within 14 dyas of enrollment to study defined as follows: N ≥ 1500/mm^3; PLT ≥ 80,000/mm^3; HB≥90g/L;total bilirubin < 1.25ULN; AST/ALT < 2.5 ULN or < 5 ULN with metastasis; SCr ≤1ULN; CCR > 50ml/min;
- •The survival period is expected to be greater than 3 months;
- •Willing to accept adequate contraception for patients with childbearing potential.
排除标准
- •Take chemotherapeutic chemotherapy (the use of low-dose chemotherapy for radiosensitization was allowed) or thalidomide and its derivative treatments;
- •Take VEGFR-TKI within 1 month, such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib;
- •Allergic to apainib;
- •Uncontrolled high blood pressure and heart disease;
- •Patients with gastrointestinal bleeding risk;
- •Coagulation disorders(INR>1.5×ULNAPTT>1.5×ULN);
- •Uroprotein positive (Uroprotein≥2+ or 24-hour urinary protein quantity >1.0g);
- •Pregnant or lactating women.
研究组 & 干预措施
Apatinib with IMRT
Experimental
Participants will receive apatinib (0.5g, daily) for two cycles followed by intensity modulated radiation therapy (Primary site and lymph nodes: 66 Gy/33F, metastatic site: 40-60Gy/20-30F)
干预措施: Apatinib (Drug)
Apatinib with IMRT
Experimental
Participants will receive apatinib (0.5g, daily) for two cycles followed by intensity modulated radiation therapy (Primary site and lymph nodes: 66 Gy/33F, metastatic site: 40-60Gy/20-30F)
干预措施: Intensity modulated radiation therapy (Radiation)
结局指标
主要结局
Progression Free Survival
时间窗: 3-year
The time from date of randomization until date of first documented disease progression or death from any cause
次要结局
- Overall survival(3-year)
- Time to Response(From the initial treatment to first response, up to 3 years)
- Duration of Response(From first response to disease progression, up to 3 years)
- Short-term treatment response rate(Three months after completion of the therapy)
- Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03(Time interval from start to 3 months after completion of the therapy)
研究者
Xiayun He, MD
Chief Physician
Fudan University
研究点 (1)
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