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 pr

Trial Details

NCT ID
NCT07059299
Phase
PHASE1
Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Status
RECRUITING
Cancer Type
Adenocarcinoma Esophageal Cancer
Interventions
  • Tislelizumab
  • FLOT Chemotherapy
Locations (sample)
  • Frankfurt, Germany|49.68333,10.53333
  • Hamburg, Germany|53.55073,9.99302
  • Leipzig, Germany|51.33962,12.37129
  • München, Germany|51.60698,13.31243

Key Eligibility Criteria

  • Patient\* has given written informed consent.
  • Patient is ≥ 18 years of age at time of signing the written informed consent.
  • Patient has histologically proven locally advanced (cT2-4 , any cN , M0 OR any cT, cN+, M0 stage) gastric, esophageal or esophagogastric junction a…
  • Is considered technically resectable.

For full eligibility, visit ClinicalTrials.gov.

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