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

NCT07059299 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-12-19

No results posted yet for this study

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.

Conditions

  • Esophagogastric Junction Adenocarcinoma
  • Gastric Adenocarcinoma
  • Esophageal Adenocarcinoma
  • Resectable Esophagogastric Adenocarcinoma
  • Neoadjuvant Therapy

Interventions

DRUG

Tislelizumab

humanized immunoglobulin G4 (IgG4)-variant monoclonal antibody (mAb) against human programmed cell death-1 (PD-1)

DRUG

FLOT Chemotherapy

docetaxel 50 mg/m², oxaliplatin 85 mg/m², leucovorin 200 mg/m² and 5-FU 2600 mg/m², all i.v. on day 1 Q2W

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • Universitätsklinikum Leipzig

    collaborator OTHER

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Florian Lordick, Prof. Dr. · Universitätsklinikum Leipzig

  • Salah Eddin Al-Batran, Prof. Dr. · Frankfurter Institut für Klinische Krebsforschung IKF GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-12
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07059299 on ClinicalTrials.gov