NCT03708822进行中（未招募）2 期
Open-Label, Multicenter, Phase Ⅱ Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年10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
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of docetaxel and cisplatin combined with Nimotuzumab in the treatment of recurrent and metastatic 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biopsy proved nasopharyngeal carcinoma;
- •stage IVB according to the eighth edition American Joint Committee on Cancer/Union for International Cancer Control staging system, or recurrent disease beyond more than 6 months after curative chemotherapy and/or radiotherapy;
- •18-70 years;
- •without other malignancy;
- •had at least one measurable disease;
- •had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •estimated life expectancy exceeding 3 months;
- •adequate functions of the major organs.
排除标准
- •allergic to docetaxel or cisplatin or nimotuzumab;
- •pregnant or lactating female;
- •patients received other clinical trails within 3 months;
- •had serious infections, comorbidities or vital organs dysfunction.
研究组 & 干预措施
Docetaxel and Cisplatin and Nimotuzumab
Experimental
All eligible patients received intravenous nimotuzumab plus docetaxel and cisplatin every 3 weeks for a maximum of 6 cycles, or until disease progression, death, intolerable toxicity.
干预措施: Docetaxel and Cisplatin and Nimotuzumab (Drug)
结局指标
主要结局
overall response rate
时间窗: up to 18 weeks
the proportion of patients achieved partial response (PR) and complete response (CR) according to RECIST v1.1
次要结局
- disease control rate(up to 18 weeks)
- duration of response(From date of documented response until the date of progressive disease [PD] or death, whichever came first, assessed up to 12 months)
- progression-free survival(From date of the enrollment until the date of the documented PD or death, whichever came first, assessed up to 12 months)
- overall survival(From date of the enrollment until the date of the documented death, assessed up to 72 months)
- adverse events(up to 18 weeks)
研究者
Qingqing Cai
Chief physician
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Study of Docetaxel for Injection (Albumin-bound) in Patients With Pancreatic CancerPancreatic CancerNCT05616494CSPC ZhongQi Pharmaceutical Technology Co., Ltd.53
招募中
2 期
A Study of Docetaxel for Injection (Albumin-bound) in Combination With Bevacizumab in Patients With Ovarian CancerPlatinum-resistant Recurrent Ovarian CancerNCT05325229CSPC ZhongQi Pharmaceutical Technology Co., Ltd.94
已完成
2 期
ACVDL Treatment for Patients With Newly Diagnosed Multiple MyelomaMultiple MyelomaNCT01481194Vejle Hospital35
已完成
2 期
Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast CancerBreast NeoplasmsNCT00446030Sanofi127
尚未招募
1 期
A Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma.Locally Advanced Unresectable Esophageal Squamous CarcinomaNCT06136988CSPC ZhongQi Pharmaceutical Technology Co., Ltd.129