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Selective serotonin reuptake inhibition in patients with advanced gastroesophageal cancer receiving immunochemotherapy: a prospective phase II trial
EU CTIS ID: 2024-518631-11-00
What this study is testing
To evaluate the ability of sertraline to further improve treatment response in combination with standard first-line immunochemotherapy in patients with metastatic, gastroesophageal, adenocarcinoma.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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.
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.