Combination of Nimotuzumab and Radiotherapy for Recurrent and Metastatic Uterine Cervical Squamous Carcinoma: a Single-arm, Open, Phase 2 Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Patients with recurrent or metastatic uterine cervical squamous carcinoma have very poor prognosis. For eligible patients, radiotherapy remains the choice, which has the most effective impact on the survival periods. On the hand, anti-angiogenic therapy has been proved to be promising treatment for recurrent or advanced cervical carcinomas. This study aims to discover the objective response of combination therapy with nimotuzumab (an anti-epidermal growth factor receptor [EGFR] IgG1 humanized monoclonal antibody) and radiotherapy in recurrent or metastatic uterine cervical squamous carcinoma in a single-arm, open, phase 2 clinical trial. The primary endpoint is the objective response rate evaluated by imaging methods. The second endpoints are the progression-free survival and overall survival. The treatment toxicity is regarded as one the second endpoint.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged more than 18 years
- •Eastern Cooperative Oncology Group score 0-1
- •Pathological confirmed of uterine cervical squamous carcinoma
- •An interval of 3 months or more since the fulfilling of last treatment
- •At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1
- •Anticipative survival period of 3 months or more
- •Lab testing within reference ranges
- •With appropriate contraception
- •Provided consents of participating the trial
排除标准
- •With a history of exposure to other antiangiogenic agents
- •With other malignancies within past 3 years
- •With vital complications
- •With uncontrolled hypertension despite of medical treatment
- •With brain metastasis
- •With addiction to psychiatric medications or with mental disorders
结局指标
主要结局
Objective response rate
时间窗: 1 years
The objective response rate includes complete and partial remission
次要结局
- Overall survival(3 years)
- Progression-free survival(2 years)
- Adverse event rates(3 years)
- Disease control rate(1 year)
研究者
Lei Li
Professor
Peking Union Medical College Hospital