Actively Recruiting
NeoTISLEGA - Phase Ib Trial of Tislelizumab Plus FLOT Chemotherapy Before Surgery 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
N/A
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
Researchers are evaluating a new combination therapy using tislelizumab and FLOT chemotherapy given before surgery (neoadjuvant) for patients with locally advanced, resectable adenocarcinoma of the esophagus or stomach. This phase Ib trial aims to determine if this combination is safe and active enough to support further studies of new drug combinations in this setting. The study also explores extending preoperative chemotherapy cycles to improve patient tolerance compared to the usual pre- and postoperative schedule. The treatment involves two dose levels in a dose intensification phase: Dose level 1 includes 4 cycles of tislelizumab (200 mg intravenously every 3 weeks) combined with 6 cycles of FLOT chemotherapy (docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil intravenously every 2 weeks). Dose level 2 increases to 5 cycles of tislelizumab plus 8 cycles of FLOT. The optimal dose level, where side effects are acceptable, will then be expanded with additional patients. The study focuses on giving more cycles before surgery to assess safety and potential clinical activity. Participants will be monitored closely during treatment for side effects and effectiveness, with assessments including physical exams, blood tests, and imaging. Researchers will measure the feasibility of delivering up to 8 months of this combined therapy before surgery. The trial will also involve checking tumor tissue for specific markers to guide treatment evaluation. The total duration includes the treatment phase and follow-up to assess patient outcomes and safety.
CONDITIONS
Brief 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.
- Patient has histologically confirmed locally advanced, resectable gastric, esophageal, or esophagogastric junction adenocarcinoma (cT2-4, any cN, M0 or any cT, cN+, M0).
- Tumor does not involve distant peritoneal sites; confirmed by diagnostic laparoscopy for certain tumor types.
- Tumor material is available for assessment of PD-L1 and dMMR/MSI status.
- Patient has an ECOG performance status of 0 or 1.
- Adequate blood counts, liver enzymes, and kidney function as specified (e.g., ANC >1,500/µL, platelet count ≥100,000/mm3, hemoglobin ≥9 g/dL).
- Female patients of childbearing potential agree to use effective contraception during treatment and for months after.
- Male patients with female partners of childbearing potential agree to use barrier contraception and avoid sperm donation during and after treatment.
You will not qualify if you...
- Prior chemotherapy, radiotherapy, or immunotherapy for the same condition or within 5 years for other cancers.
- Previous partial or complete esophagogastric surgery.
- Known hypersensitivity to study drugs or related antibodies.
- History or presence of pneumonitis or interstitial lung disease requiring steroids.
- Significant lung diseases such as severe asthma or COPD.
- Cardiac dysfunction (LVEF <50%) or recent myocardial infarction.
- Complete absence of dihydropyrimidine dehydrogenase (DPD) activity.
- Recent treatment with certain antiviral drugs.
- Vitamin B12 deficiency-related anemia.
- Peripheral neuropathy with functional deficits.
- Prolonged QT interval on ECG.
- Active or recent additional malignancies requiring treatment.
- Uncontrolled infections or active hepatitis B, C, or HIV infections.
- Active or history of autoimmune diseases.
- Recent use of systemic immunostimulants or immunosuppressants.
- Prior allogeneic bone marrow or solid organ transplantation.
- Recent live attenuated vaccine.
- Other serious medical conditions increasing risk or reducing likelihood of benefit.
- Participation in other interventional clinical studies within 28 days.
- Female patients who are pregnant, breastfeeding, or planning pregnancy within 7 months after last dose.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 to 6 months depending on dose level and cycles
Participants receive a combination of Tislelizumab and FLOT chemotherapy before surgery.
Multiple infusions: 4 to 5 cycles of Tislelizumab every 3 weeks and 6 to 8 cycles of FLOT chemotherapy every 2 weeks
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.
C
Claudia Pauligk, Dr.
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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