A Phase Ib Trial Evaluating the Safety and Activity of Neoadjuvant Combination of Tislelizumab Plus FLOT for Resectable Esophagogastric Adenocarcinoma

With this trial, we aim to evaluate a new combination therapy with tislelizumab and FLOT chemotherapy before surgery (neoadjuvant) for locally advanced, resectable adenocarcinoma of the esophagus or stomach (EGA). The aim of this phase Ib trial is to determine whether this combination is safe and clinically active enough to support the continuation of this concept in subsequent trials investigating novel drug combinations in the neoadjuvant setting of locally advanced EGA. As many patients are unable to tolerate the postoperative part of the standard therapy concept, we aim here to assess a prolongation of preoperative therapy to 6 or 8 applications of FLOT, instead of the routinely administered 4 pre- and 4 postoperative applications, in combination with tislelizumab.

NCT Number	NCT07059299
Lead Sponsor	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Collaborators: BeiGene, Universitätsklinikum Leipzig
Conditions	Esophagogastric Junction Adenocarcinoma, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Resectable Esophagogastric Adenocarcinoma, Neoadjuvant Therapy
Enrollment	18 participants
Start Date	2025-12-12
Primary Completion	2027-08 (estimated)
Study Completion	2027-08 (estimated)
Updated on ClinicalTrials.gov	2025-12-19