EUCTR2019-001641-40-IT进行中（未招募）1 期
Induction Durvalumab (MEDI4736) & Radiotherapy (RT) forLocally Advanced but Resectable Head and Neck Squamous Cell Carcinomas: A Pilot Study - ESR-17-12933
ISTITUTI FISIOTERAPICI OSPITALIERI0 个研究点目标入组 14 人开始时间: 2021年5月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Newlydiagnosed,histologicallyconfirmedsquamouscellcarcinomaoftheoralcavity,pharynxand larynx;
- •Selected UICC stage IV disease limited to T1-3N2-3 or T4N1-3disease;
- •No distant metastases (M0)
- •Lesions (both primary and nodal) must be considered amenable of complete surgicalresection;
- •Patient must be cleared for surgery (medicallyoperable);
- •Age >18 yrs and < 80yrs;
- •Eastern cooperative oncology group (ECOG) performance status of 0 or1.
- •Body weight>30kg
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •cN0 disease even if stage IV;
- •Definitive clinical or radiologic evidence of distant metastatic disease(M1);
- •Carcinoma of the head and neck of unknown primary site origin or lack of a visible primarysite;
- •Prior head neck regionirradiation;
- •Synchronous primarycancers;
- •Any other previous malignancy within 5years;
- •Active, known, or suspected autoimmune disease. Type I diabetes mellitus, hypothyroidismonly
- •requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed
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