Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Safety of Nimotuzumab combined with Radiotherapy for older patients
研究概览
简要总结
For patients who are unable to receive surgery or having local advanced esophageal cancer stages, concurrent chemoradiotherapy is recommended. But radiotherapy is the main strategy for older patients because of their chemoradiotherapy intolerance. The whole world focused on targeted therapy which has strong specialties and mild toxicities. So combined targeted therapy and radiotherapy may be a novel strategy for older patients with esophageal cancer. Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and safety of Nimotuzumab in combined with radiotherapy for older patients with esophageal cancer. All patients receive intensity modulated radiotherapy with conventional fraction. Nimotuzumab with 200mg is given weekly for all patients during radiotherapy.
详细描述
Study Design Primary Purpose: To evaluate the response rate, progression-free survival, overall survival and complications.
Study Phase: Phase II Intervention Model: Targeted therapy combined with radiotherapy Number of Arms: One Masking: No Allocation: 30 patients for one single group Enrollment: 30 patients
Eligibility Criteria Inclusion Criteria: 1. ≥ 70 year-old, 2. Thoracic segment esophageal cancer with stage II to IV (supraclavicular lymph node metastasis only), 3. No previous surgery, radiotherapy or chemotherapy of cancer was allowed, 4. Estimated survival time ≥ 3 months, 5. KPS > 60, 6. No serious diseases of important organs, 7. Signed consent forms voluntarily.
Exclusion Criteria: 1. Psychopath, 2. History of other malignant disease which has not been cured, 3. Joining other clinical trial prior this 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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 70 years or older;
- •treatment naive patients with histologically proven thoracic-segment EC that was inoperable and who could not tolerate CCRT;
- •stage II-IV disease (supraclavicular lymph node metastasis only), according to the 6th American Joint Committee on Cancer TNM staging system;
- •estimated survival time ≥3 months;
- •Karnofsky performance score ≥70;
- •adequate bone marrow, as well as hepatic and renal function;
- •voluntary written consent provided prior to treatment.
排除标准
- •esophagobronchial or esophagomediastinal fistula;
- •patients who had joined other clinical trials prior to this treatment;
- •serious heart, liver, and/or kidney insufficiency;
- •serious infectious disease;
- •relapse disease or distant metastasis;
- •recently diagnosed neoplastic diseases;
- •previous receipt of surgery, chemotherapy, or radiotherapy for EC.
研究组 & 干预措施
radiotherapy
It is just a single group assignment
干预措施: Nimotuzumab (Drug)
结局指标
主要结局
Safety of Nimotuzumab combined with Radiotherapy for older patients
时间窗: 2 years
To observe the adverse events during the treatment
次要结局
- Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients(3 years)
研究者
Liang Jun
Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences