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Study on Sertraline with Immunochemotherapy for Patients with Advanced Gastroesophageal Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called sertraline in patients with advanced gastroesophageal cancer. Gastroesophageal cancer is a type of cancer that affects the stomach and the area where the stomach meets the esophagus. The study aims to see if adding sertraline to the usual treatment can improve the response to therapy. The usual treatment for these patients is a combination of drugs known as immunochemotherapy, which helps the immune system fight cancer.

Participants in the study will receive sertraline in addition to their standard immunochemotherapy treatment. The study will observe how well the cancer responds to this combination over a period of time. The medication sertraline is taken orally, meaning it is swallowed in the form of a tablet. The study will last for a specific period, during which the effects of the treatment will be closely monitored.

The main goal of the study is to evaluate how well the cancer responds to the treatment combination. Researchers will also look at other important factors such as how long patients live without the cancer getting worse, overall survival, any side effects experienced, and the quality of life of the participants. Additionally, the study will assess the impact of the treatment on depression, as sertraline is commonly used to treat this condition. The findings from this study could provide valuable insights into improving treatment options for patients with advanced gastroesophageal cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate after understanding the purpose and procedures of the study.
You will undergo a screening process to confirm your eligibility. This includes confirming a diagnosis of advanced gastroesophageal cancer and ensuring you meet other health criteria.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your current health status. This may include physical exams, blood tests, and imaging studies to measure your disease.
Step 3
Treatment phase
You will begin treatment with a combination of standard immunochemotherapy and the study medication, sertraline. Sertraline is taken orally as a 50 mg film-coated tablet.
The frequency and duration of sertraline administration will be determined by the study protocol and your healthcare provider.
Step 4
Ongoing monitoring
Throughout the study, you will have regular appointments to monitor your response to treatment. This includes evaluating the effectiveness of the therapy and checking for any side effects.
You will be assessed for progression-free survival, overall survival, and quality of life. Depression scale analyses will also be conducted to monitor your mental health.
Step 5
End of study participation
Your participation in the study will conclude at the end of the study period or if you choose to withdraw. The estimated end date for the study is October 31, 2025.
At the end of your participation, a final assessment will be conducted to evaluate your overall health and treatment outcomes.

Who can join the trial?

8 criteria

Ability to understand the purpose of the study and provide written consent to participate.
Diagnosis confirmed by a doctor of gastric/gastroesophageal junction/esophageal adenocarcinoma (a type of cancer in the stomach or esophagus).
Presence of measurable disease according to specific medical criteria (RECIST version 1.1).
Plan to receive first-line palliative immunochemotherapy (a combination of chemotherapy and immunotherapy) with FOLFOX/CAPOX and nivolumab as part of routine treatment.
Age 18 years or older.
ECOG-PS 0-2: A performance status scale that measures how the disease affects daily living abilities, where 0 means fully active and 2 means capable of all self-care but unable to carry out any work activities.
Have adequate function of bone marrow, liver, and kidneys.
Women who can become pregnant must have a negative pregnancy test before starting the study and use approved birth control methods during the study. Approved methods include hormonal birth control, intrauterine device, double barrier method, or total abstinence.

Who cannot join the trial?

9 criteria

Patients who have a different type of cancer than gastroesophageal cancer.
Patients who are not within the specified age range for the study.
Patients who are not able to receive the standard first-line treatment for their condition.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to give informed consent to participate in the study.
Patients who have participated in another clinical trial recently.
Patients who have allergies or adverse reactions to the study medication or similar drugs.
Patients who have a history of substance abuse or mental health conditions that might affect their participation.

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Medical University Of Vienna
Vienna, Austria

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Investigated drugs

Sertraline is a medication commonly used to treat depression and anxiety. In this clinical trial, it is being tested to see if it can help improve the effectiveness of cancer treatment in patients with advanced gastroesophageal cancer. The researchers want to find out if adding sertraline to the standard cancer treatment can help patients respond better to the therapy.

Sertraline

What is already known about the treatment

Sertraline – Sertraline is administered orally in the form of tablets or capsules. It is currently being studied in clinical trials for its potential to enhance the effectiveness of standard immunochemotherapy in patients with advanced gastroesophageal cancer. The main therapeutic indication being explored is its use in combination with cancer treatment to improve patient outcomes. At the molecular level, sertraline works by selectively inhibiting the reuptake of serotonin, a neurotransmitter, which can influence mood and potentially affect cancer treatment response. It is classified pharmacologically as a selective serotonin reuptake inhibitor (SSRI).

Investigated diseases

Gastroesophageal cancer – Gastroesophageal cancer is a type of cancer that occurs where the esophagus meets the stomach. It often begins in the cells lining the inside of the esophagus or stomach and can develop into a tumor. As the disease progresses, the cancer can invade deeper layers of the esophagus or stomach wall and may spread to nearby lymph nodes and other organs. Symptoms may include difficulty swallowing, weight loss, and chest pain. The progression of the disease can lead to obstruction of the esophagus or stomach, causing further complications. Over time, the cancer may metastasize to distant parts of the body, affecting overall health and function.