Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2027-08-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

PHASE1

Details

Lead Sponsor:

Institut fr Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborators:

BeiGene
Universittsklinikum Leipzig

Treatments:

tislelizumab