Actively Recruiting
A Phase Ib Trial Evaluating the Safety and Activity of Neoadjuvant Combination of Tislelizumab Plus FLOT for Resectable Esophagogastric Adenocarcinoma
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2025-12-19
18
Participants Needed
4
Research Sites
85 weeks
Total Duration
On this page
Sponsors
I
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Phase Ib Trial Evaluating the Safety and Activity of Neoadjuvant Combination of Tislelizumab Plus FLOT for Resectable Esophagogastric Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has given written informed consent.
- Patient is 18 years of age or older at the time of consent.
- Patient has locally advanced (cT2-4, any cN, M0 or any cT, cN+, M0 stage) gastric, esophageal, or esophagogastric junction adenocarcinoma that is technically resectable.
- Tumor does not involve distant sites of the peritoneal cavity, confirmed by diagnostic laparoscopy for stomach tumors and type 2 and 3 GEJ adenocarcinomas; type 1 GEJ and esophageal adenocarcinomas may enroll without laparoscopy.
- Tumor material is available for local PD-L1 and dMMR/MSI status assessment.
- Patient has ECOG performance status 0 or 1.
- Patient has adequate blood counts, liver enzymes, and kidney function as defined by specific laboratory criteria.
- Female patients of childbearing potential agree to abstain or use effective contraception during treatment and for 4 months after last dose of tislelizumab or 6 months after last dose of chemotherapy, whichever is later.
- Male patients with partners of childbearing potential agree to abstain or use barrier contraception during the same period and refrain from donating sperm.
You will not qualify if you...
- Prior chemotherapy, radiotherapy, or immunotherapy for the same cancer or any other cancer within the past 5 years.
- Prior partial or complete esophagogastric resection.
- Known hypersensitivity to tislelizumab components or severe allergic reactions to monoclonal antibodies or study drugs.
- History of pneumonitis or interstitial lung disease requiring steroids or current lung disease.
- Significant lung illnesses such as recent pulmonary embolism, severe asthma, COPD, restrictive lung disease, or pleural effusion.
- Inadequate cardiac function (left ventricular ejection fraction below 50%).
- Complete absence of dihydropyrimidine dehydrogenase (DPD) activity.
- Recent treatment with brivudine, sorivudine, or related drugs within 28 days.
- Pernicious anemia or megaloblastic anemia due to vitamin B12 deficiency.
- Peripheral neuropathy with functional deficits.
- Recent myocardial infarction within 6 months or symptomatic congestive heart failure.
- Prolonged corrected QT interval on ECG.
- Active progressing additional malignancy or recent active treatment for another cancer.
- Uncontrolled infections requiring intravenous antibiotics or antivirals.
- Active primary immunodeficiency or uncontrolled active HIV or hepatitis B or C infections.
- Active or history of autoimmune diseases such as myasthenia gravis, lupus, rheumatoid arthritis, and others.
- Recent treatment with systemic immunostimulatory agents or corticosteroids.
- Prior bone marrow or solid organ transplantation.
- Recent live attenuated vaccine within 30 days.
- Other serious medical conditions posing high risk or reducing clinical effect likelihood.
- Participation in another interventional clinical study within 28 days or concurrent participation unless observational or during follow-up.
- Use of investigational drugs within 28 days prior to study drug initiation.
- Pregnancy, breastfeeding, or planning pregnancy within 7 months after last treatment dose; female patients of childbearing potential must have a negative pregnancy test before treatment.
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Krankenhaus Nordwest GmbH Institut für Klinisch-Onkologische Forschung (IKF)
Frankfurt, Germany, 60488
Actively Recruiting
2
Hämatologisch-Onkologische Praxis Eppendorf (hope)
Hamburg, Germany, 20249
Not Yet Recruiting
3
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Not Yet Recruiting
4
Klinikum rechts der Isar München der TU München
München, Germany, 81675
Actively Recruiting
Research Team
F
Florian Lordick, Prof. Dr.
CONTACT
C
Claudia Pauligk, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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