NCT03591666Unknown2 期
A Non-randomized Phase II Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2018年7月15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
- 51
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a non-randomized, phase II, open label study of anlotinib hydrochloride capsules in recurrent/metastatic adenocarcinomas of head and neck. The primary purpose of this study is to evaluate the efficacy of anlotinib.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed head and neck adenocarcinoma.
- •Patients with recurrent or metastatic head and neck adenocarcinoma who are not candidates for curative surgery or radiotherapy.
- •Measurable disease per the RECIST criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Provision of written informed consent.
- •Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (IUD, birth control pills, or barrier device) during and for 3 months after completion of trial therapy.
排除标准
- •Prior treatment with Anlotinib
- •With pleural effusion or ascites, cause respiratory syndrome
- •Accepted the vascular endothelial growth inhibitor class targeted drug treatment of patients
- •Plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, 5.Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping
- •6.Symptoms of brain metastases cannot be controlled and treated within less than 2 months 7.severe and failed to controlled diseases 8.Occurred venous thromboembolic events within 6 months
研究组 & 干预措施
Study Group
Experimental
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Anlotinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 24 months
次要结局
- Progress free survival (PFS)(up to 24 months)
- Disease Control Rate (DCR)(up to 24 months)
- Overall Survival (OS)(up to 24 months)
研究者
研究点 (1)
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