2024-518631-11-00招募中2 期
Selective serotonin reuptake inhibition in patients with advanced gastroesophageal cancer receiving immunochemotherapy: a prospective phase II trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The primary endpoint of this study is the rate of best responses per any timepoint during study period after administration of at least one cycle of immunochemotherapy defined as CR and PR according to RECIST 1.1 criteria
研究概览
简要总结
To evaluate the ability of sertraline to further improve treatment response in combination with standard first-line immunochemotherapy in patients with metastatic, gastroesophageal, adenocarcinoma.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Capability of understanding the purpose of the study and have given written informed consent. • Histologically confirmed gastric/gastroesophageal junction/esophageal adenocarcinoma • Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) • Patients who are planned to first-line palliative immunochemotherapy (FOLFOX/CAPOX + nivolumab) in routine, indication and according to the marketing authorization • Age ≥ 18 years • ECOG-PS 0-2 • Adequate bone-marrow, liver and kidney function • Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days before first administration of IMP. Approved methods of birth control must be used in women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to the last dose XML File Identifier: 51bQzQYkow8BoTwrtT9YKUHXaRs= Page 10/20 of protocol therapy. Adequate contraception defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
排除标准
- •at time of screening • Use of monoamine oxidase inhibitors (MAOIs), pimozide, phenytoin or linezolid within 28 days of study initiation • Allergy or intolerability to the test drug • Moderate or severe hepatic impairment (Child-Pugh score ≥7) • QTc in ECG ≥450ms in adult men and ≥460ms in adult woman • Sodium levels ≤ 129mmol/L • History of bipolar disorder or mania • History of seizures or convulsions • History of stroke • History of cardiac arrhythmia • Use of any investigational agent within 28 days prior to initiation of study treatment • Pregnant or lactating women • Male subjects unable or unwilling to use adequate contraception methods • Patients with substance abuse disorder or any other medical conditions such as clinically significant neurological or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results
结局指标
主要结局
The primary endpoint of this study is the rate of best responses per any timepoint during study period after administration of at least one cycle of immunochemotherapy defined as CR and PR according to RECIST 1.1 criteria
The primary endpoint of this study is the rate of best responses per any timepoint during study period after administration of at least one cycle of immunochemotherapy defined as CR and PR according to RECIST 1.1 criteria
次要结局
- • Progression-free survival • Overall survival • Toxicity • Quality of life analyses • Depression scale analyses
研究者
Department of Medicine I ,Division of Oncology
Scientific
Medical University Of Vienna
研究点 (1)
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