Phase II Trial of Nimotuzumab Combined With Volumetric Modulated Arc Therapy in Elderly Patients With Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Complete remission rate
研究概览
简要总结
To evaluate the efficacy and toxicity of Nimotuzumab combined with VMAT in the treatment of elderly patients with nasopharyngeal carcinoma (> 70 years old), and to provide high-level clinical evidence for the optimal treatment of elderly patients with nasopharyngeal carcinoma.
详细描述
The incidence of elderly patients with nasopharyngeal carcinoma is increasing with a rapidly ageing population. However, the prognosis is worse than that of young patients. Some patients can benefit from intensive treatment such as concurrent chemoradiotherapy, but are always with obvious toxicity. With the advancement of radiotherapy technology and the emergence of molecular targeted drugs, radiotherapy combined with Nimotuzumab has shown good therapeutic efficacy and tolerance. The investigators plan to testify VMAT combined with Nimotuzumab in elderly patients with nasopharyngeal carcinoma.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pathology confirmed squamous cell carcinoma of nasopharynx; Aged ≥ 70 years old; Stage III-IVB diseases according to 8th AJCC Staging; Treatment for the first time; ECOG scores ≤ 1; Normal hepatic, renal and bone-marrow function; ACE-27 scores ≤2; Life expectancy≥12 weeks; Can understand and sign the consent.
排除标准
- •Past malignancies history (except for non-melanoma skin cancer or cervical carcinoma in situ or cured prostate cancer of early stage); Allergic to Nimotuzumab; Severe comorbidities including cardiovascular, cerebral vascular, mental and uncontrolled diabetes disease; Chemotherapy, surgery or other molecule-target treatment; Severe malnutrition.
研究组 & 干预措施
VMAT plus Nimotuzumab
Patients receive Nimotuzumab weekly during radiotherapy .
干预措施: Nimotuzumab (Drug)
VMAT plus Nimotuzumab
Patients receive Nimotuzumab weekly during radiotherapy .
干预措施: VMAT (Radiation)
结局指标
主要结局
Complete remission rate
时间窗: 4 months
Complete remission rate will be measured by RECIST 1.1
次要结局
- local control rate(2 years)
- regional control rate(2 years)
- acute treatment toxicity(up to 16 weeks)
- Quality of Life Assessment(2 years)
- late treatment toxicity(2 years)
研究者
Jun-Lin Yi, MD
Chief physician
Chinese Academy of Medical Sciences