RecruitingPHASE1INTERVENTIONAL

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

This research study is looking at a new way to treat a type of cancer that affects the stomach or the tube leading to it (gullet), specifically when it can be surgically removed. We're testing a combination of two treatments: a drug called Tislelizumab and the usual FLOT chemotherapy. Both are given before surgery. The main goal is to find out if this combination is safe for patients and if it shows promising signs of working. We're also exploring whether giving chemotherapy for a longer period before surgery might be better, especially since some patients find the recovery after surgery difficult. This first stage of the trial helps us decide if this treatment is good enough to study in larger groups of patients later on.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrolment target

Start

12 Dec 2025

Estimated completion

01 Aug 2027

Esophagogastric Junction Adenocarcinoma Gastric Adenocarcinoma Esophageal Adenocarcinoma Resectable Esophagogastric Adenocarcinoma Neoadjuvant Therapy

What is this study about?

This study is about finding better ways to treat a specific type of cancer that can develop in the stomach or the food pipe (gullet). This cancer is called adenocarcinoma, and the study focuses on cases where the cancer can be removed with surgery.

Currently, many patients receive chemotherapy both before and after their operation. However, sometimes patients find it hard to complete the full course of treatment after surgery because they are recovering from the operation. This study is exploring if giving more of the chemotherapy before surgery, in combination with a new drug, might be a more effective and manageable approach.

The new drug being tested is called Tislelizumab, and it's being combined with a standard chemotherapy treatment known as FLOT. Researchers want to see if this combination, given before surgery, is safe for patients and if it has a good effect on the cancer. This is an early-stage study (Phase 1), which means we're primarily focused on safety and getting initial signs that the treatment is active. If successful, it could lead to further, larger studies.

Key takeaways

This study is for stomach or gullet cancer that can be removed with surgery.
It tests a new combination of Tislelizumab (immunotherapy) and FLOT chemotherapy before surgery.
The aim is to check if this new approach is safe and shows promise.
Researchers are exploring if longer pre-surgery treatment is better for patients.
It's an early-stage trial focused on safety.
You can stop participating at any time if you join.

Who may be eligible?

To join this study, you must be at least 18 years old and have a specific type of cancer in your stomach or gullet that doctors believe can be fully removed by surgery. This means the cancer shouldn't have spread far to other parts of your body, especially not into the lining of your abdomen.

We would also need a small sample of your tumour tissue to test for certain markers. Before you can join, doctors will check your overall health, including blood tests for your blood count, kidney, and liver function, to make sure you are well enough to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I 18 years old or older?
Do I have stomach or gullet cancer that doctors think can be surgically removed?
Is my general health good enough for treatment (e.g., healthy blood, liver, kidneys)?
Am I willing to provide a tumour tissue sample for testing?
Am I able to visit the hospital regularly for treatments and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll receive the Tislelizumab drug along with FLOT chemotherapy before your surgery. The FLOT chemotherapy might be given for a longer period (6 or 8 cycles) compared to the standard 4 cycles usually given before surgery. You will have regular hospital visits for your treatments and check-ups. Doctors will monitor your health closely throughout this period and after your surgery. The exact number of visits and tests will be explained in detail by the study team, but generally it would involve regular appointments over several months for treatment and then follow-up appointments.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might receive a new treatment that could be more effective than standard options, but there's also a chance it might not help your condition or could have side effects. Doctors will carefully monitor you for any side effects, and you will be fully informed about known risks. It's important to remember that joining a study is always a personal choice, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Krankenhaus Nordwest GmbH Institut für Klinisch-Onkologische Forschung (IKF)
Verified postcode
Frankfurt, Germany· Recruiting
Hämatologisch-Onkologische Praxis Eppendorf (hope)
Verified postcode
Hamburg, Germany· Not yet recruiting
Universitätsklinikum Leipzig
Verified postcode
Leipzig, Germany· Not yet recruiting
Klinikum rechts der Isar München der TU München
Verified postcode
München, Germany· Recruiting

Common questions

What is 'neoadjuvant therapy'?

Neoadjuvant therapy means treatment given before your main treatment, like surgery, to try and shrink the cancer or make the surgery more effective.

What is Tislelizumab?

Tislelizumab is a type of immunotherapy drug. It helps your body's immune system fight cancer cells more effectively.

What is FLOT chemotherapy?

FLOT is a standard combination of different chemotherapy drugs often used to treat stomach and gullet cancers.

Will I still have surgery?

Yes, this study is for patients whose cancer can be removed by surgery. The treatments in this study are given before your operation.

What does Phase 1 mean?

Phase 1 trials are the earliest stage of human testing for a new treatment. They mainly focus on whether the treatment is safe and to find the right dosage, rather than how well it works.

How to find out more

Florian Lordick, Prof. Dr.

florian.lordick@medizin.uni-leipzig.de +49 341 97 12560 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.