CTIS2024-516189-12-00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 Raffaele S.r.l.0 个研究点目标入组 20 人开始时间: 2024年7月12日最近更新:
适应症
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
入排标准
- 年龄范围
- 18 至 65+（—）
- 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
排除标准
- •Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines4, Any regular concomitant medication which is contraindicated in the use together with HCQ, Diabetes type 1, Haematopoietic systems diseases, Myasthenia gravis, Psoriasis, Pregnant or breastfeeding women, Patients with Nasogastric or PEG feeding tube, Patients with deterioration of performance status beyond ECOG 2, Bradycardia or reduction in heart rhythm with arrhythmia, Uncorrected hypokalemia and/or hypomagnesemia, Ischemic heart disease (< 5 years), 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.
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