Phase Ib Evaluation of Neoadjuvant Tislelizumab Plus FLOT in Resectable Esophagogastric Adenocarcinoma

The primary objective of the NeoTISLEGA trial is to evaluate the **safety** and **activity** of a neoadjuvant combination therapy consisting of **tislelizumab** and **FLOT** in patients with **resectable esophagogastric adenocarcinoma**. This study aims to determine the potential benefits of this combination therapy in improving surgical outcomes and overall treatment efficacy for this specific type of cancer. The clinical relevance lies in the potential to enhance preoperative treatment strategies, thereby improving patient prognosis and survival rates.

The clinical trial involves participants diagnosed with **resectable esophagogastric adenocarcinoma**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial population was selected to include a vulnerable population, although specific details regarding the total number of participants have not been provided by the sponsor. The selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been disclosed. The trial aims to gather data from a diverse group of participants to ensure comprehensive insights into the condition under investigation.

The clinical trial is designed to evaluate the safety and activity of a neoadjuvant combination therapy involving **tislelizumab** plus FLOT for patients with **resectable esophagogastric adenocarcinoma**. This study is structured as a phase Ib trial, which is randomized, double-blind, and controlled, ensuring that neither the participants nor the researchers know who is receiving the treatment or placebo, thus minimizing bias. The trial is expected to commence recruitment on September 1, 2025, and is projected to conclude by March 1, 2028, encompassing a total duration of approximately 30 months.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed. This visit is crucial for determining the suitability of participants for the trial. Following successful inclusion, participants will attend regular follow-up visits, which are scheduled to monitor the safety and efficacy of the treatment regimen. These visits will include assessments such as physical examinations, laboratory tests, and imaging studies to evaluate the response to the treatment. The end-of-study visit marks the conclusion of the participant's involvement, where final evaluations are conducted to gather comprehensive data on the treatment's impact.

The expected length of participant involvement in the trial is contingent upon the treatment regimen and follow-up schedule, typically spanning several months. However, certain conditions may necessitate early termination from the study, such as adverse reactions to the treatment, withdrawal of consent by the participant, or any other medical or ethical considerations that may arise during the trial. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided dataset. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on September 1, 2025, with an estimated completion date of March 1, 2028. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methods for measuring and analyzing efficacy parameters will adhere to standard clinical trial protocols, ensuring the reliability and validity of the results. The trial's design and execution will be aligned with regulatory requirements and scientific standards to evaluate the therapeutic benefits accurately.