RecruitingPhase 1NCT07059299

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

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


Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrollment

18 participants

Start Date

Dec 12, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding tislelizumab (an immunotherapy drug) to standard pre-surgery chemotherapy (called FLOT) improves outcomes for people with resectable (surgically removable) cancer of the stomach, esophagus, or the junction between the two. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with locally advanced gastric, esophageal, or gastroesophageal junction cancer confirmed by tissue biopsy - Your cancer has not spread to distant organs (no metastases) - Your tumor is considered surgically removable - You are in good overall health and have not received prior treatment for this cancer **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body - You have previously received chemotherapy or immunotherapy for this cancer - You have active autoimmune disease or are on ongoing steroid treatment - You have significant heart, liver, kidney, or bone marrow problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

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

DRUGFLOT 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


Locations(4)

Krankenhaus Nordwest GmbH Institut für Klinisch-Onkologische Forschung (IKF)

Frankfurt, Germany

Hämatologisch-Onkologische Praxis Eppendorf (hope)

Hamburg, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Klinikum rechts der Isar München der TU München

München, Germany

View Full Details on ClinicalTrials.gov

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NCT07059299


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