EUCTR2021-004189-37-IT进行中（未招募）1 期
Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Non-small cell lung cancer - HCQHNLcancer
OSPEDALE SAN RAFFAELE0 个研究点目标入组 20 人开始时间: 2021年8月31日最近更新:
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
- 20
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
- •Head and Neck Cancer group:
- •-Adults > or = 18 years of age.
- •-American Joint Committee on Cancer-defined clinical stage I, II, III, IV HN cancer that is deemed locally to be surgically resectable by a multidisciplinary clinical team and will receive radical surgery.
- •-Squamous Cell Carcinoma (SCC) of the oral cavity or larynx
- •-Treatment-naïve patients
- •-Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •-Patient capable giving informed consent
- •-QTc interval lower than 450 msec
- •-Measurable or evaluable disease defined by RECIST 1.1
- •-For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of drug administration.
- •-For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
- •Non-small cell lung cancer group
- •-Adults > or = 18 years of age.
- •-American Joint Committee on Cancer-defined clinical stage IA, IB, IIA, IIB NSCLC that is deemed locally to be surgically resectable by a multidisciplinary clinical team and will receive radical surgery.
- •-Lung Squamous Cell Carcinoma or Adenocarcinoma.
- •-Treatment-naïve patients
- •-PDL1 > 50%
- •-Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •-Patient capable giving informed consent
- •-QTc interval lower than 450 msec
- •-Measurable or evaluable disease defined by RECIST 1.1
- •-For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of drug administration.
- •-For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •-Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines4
- •-Bradycardia or reduction in heart rhythm with arrhythmia
- •-Uncorrected hypokalemia and/or hypomagnesemia
- •-Ischemic heart disease
- •-Congestive heart failure with use of diuretics
- •-Pre-existing retinopathy or maculopathy5
- •-Known Glucose-6-phosphate dehydrogenase deficiency (haemolytic anaemia, Favism)
- •-Known galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
- •-Known prolonged QT syndrome or current use of drugs with known prolongation of QT/QTc interval.
- •-Any regular concomitant medication which is contraindicated in the use together with HCQ
- •-Diabetes type 1
- •-Haematopoietic systems diseases
- •-Myasthenia gravis
- •-Pregnant or breastfeeding women
- •-Patients with Nasogastric or PEG feeding tube
- •-Patients with deterioration of performance status beyond ECOG 2
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