What is tislelizumab studying for esophagogastric adenocarcinoma?

Tislelizumab is being studied in combination with FLOT chemotherapy to evaluate its safety and activity before surgery in patients with locally advanced esophagogastric adenocarcinoma. This trial aims to find out if this approach can improve treatment options. The study is sponsored by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest.

Who may be eligible for this esophagogastric adenocarcinoma clinical trial?

Adults aged 18 years or older with locally advanced, resectable adenocarcinoma of the esophagus, stomach, or esophagogastric junction may be eligible regardless of gender. Important factors include having good overall health, no prior cancer treatments for this condition, and meeting blood and organ function requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this esophagogastric adenocarcinoma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered by the trial. Participants should plan accordingly.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID07059299

Phase Ib Study of Tislelizumab Combined with Extended FLOT Chemotherapy Before Surgery for Locally Advanced Resectable Esophagogastric Adenocarcinoma

Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2025-12-19

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 18Years +

All Genders

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.

Research Team

Florian Lordick, Prof. Dr.

Claudia Pauligk, Dr.

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