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.
Patient* has given written informed consent.
Patient is ≥ 18 years of age at time of signing the written informed consent.
Is considered technically resectable.
Does not involve distant site of the peritoneal cavity.
Patient received previous (radio)chemotherapy or immunotherapy for the same condition or within the past five years for any other cancerous condition.
Patient received prior partial or complete esophagogastric resection.
Patient has known hypersensitivity to any component of the tislelizumab formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein and/or any known contraindication (including hypersensitivity) to one of the study drugs.
Patient has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Single group
Tislelizumab
Drughumanized immunoglobulin G4 (IgG4)-variant monoclonal antibody (mAb) against human programmed cell death-1 (PD-1)
FLOT Chemotherapy
Drugdocetaxel 50 mg/m², oxaliplatin 85 mg/m², leucovorin 200 mg/m² and 5-FU 2600 mg/m², all i.v. on day 1 Q2W
Feasibility rate
Feasibility rate, defined as proportion of patients receiving the protocol treatment before surgery ('neoadjuvant') according to the planned schedule without occurrence of at least one dose-limiting toxicity (DLT).
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Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead sponsor
BeiGene
Collaborator
Universitätsklinikum Leipzig
Collaborator
