A Phase Ib Trial Evaluating the Safety and Activity of Neoadjuvant Combination of Tislelizumab Pl… (NCT07059299) | Clinical Trial Compass
RecruitingPhase 1
A Phase Ib Trial Evaluating the Safety and Activity of Neoadjuvant Combination of Tislelizumab Plus FLOT for Resectable Esophagogastric Adenocarcinoma
Germany18 participantsStarted 2025-12-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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 adenocarcinoma that:
✓. Is considered technically resectable.
✓. Does not involve distant site of the peritoneal cavity.
✓. Tumor material is available for local assessment of PD-L1 (CPS) and dMMR/MSI-status at the investigator´s site.
✓. Patient has an ECOG performance status 0 or 1.
✓. Patients has adequate blood count, liver-enzymes, and renal function:
Exclusion criteria
✕. Patient received previous (radio)chemotherapy or immunotherapy for the same condition or within the past five years for any other cancerous condition.
What they're measuring
1
Feasibility rate
Timeframe: up to 8 months
Trial details
NCT IDNCT07059299
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
. 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.
✕. Patient has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within three months of the study randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.).
✕. Patient has inadequate cardiac function (LVEF value \< 50 %) as determined by echocardiography.
✕. Patient has a known complete absence of dihydropyrimidine dehydrogenase (DPD) activity.
✕. Patient received treatment with brivudine, sorivudine or their chemically related analogues within 28 days prior to study enrollment.