Active not recruitingPHASE2INTERVENTIONAL

Study of Atezolizumab + FLOT vs. FLOT Alone in Patients With GC/GEJ and High Immune Responsiveness

This research study is investigating a new treatment approach for people with stomach cancer or cancer where the food pipe meets the stomach (gastroesophageal junction adenocarcinoma). The study compares two groups: one receiving a new drug called atezolizumab along with standard chemotherapy (FLOT), and another receiving only FLOT chemotherapy. This treatment is given before and after surgery. Researchers are looking for people whose cancer has specific features that suggest their immune system might respond well to the new drug. The main goal is to find out if adding atezolizumab to FLOT is safer and more effective than FLOT alone in these patients. It's a 'Phase 2' study, meaning it's still in the earlier stages of testing.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrolment target

677

Start

14 Sep 2018

Estimated completion

31 Dec 2027

Gastric Cancer Gastroesophageal Junction Adenocarcinoma

What is this study about?

This clinical trial is designed to investigate a new way to treat certain types of stomach cancer or cancer of the food pipe (oesophagus) where it joins the stomach. These are often called gastric or GEJ cancers. The study involves a new drug called atezolizumab, which is a type of immunotherapy. Immunotherapy works by helping your body's own immune system fight cancer cells.

The researchers want to see if combining atezolizumab with a standard chemotherapy treatment called FLOT is more effective and just as safe as using FLOT chemotherapy on its own. This treatment is given in cycles both before and after surgery. The study is particularly interested in patients whose cancer shows specific signs indicating their immune system might respond well to atezolizumab. These signs include things like 'MSI-high' or 'PD-L1 positive' markers found in the cancer cells.

This is a Phase 2 study, which means it's an earlier stage of research. It's focused on understanding if the new treatment combination is promising enough to be studied in a larger group of people later. The participants are randomly assigned to one of two groups: one gets the new drug combination and the other gets chemotherapy alone. This helps the researchers compare the two treatments fairly and understand the potential benefits and side effects of each.

Key takeaways

Compares a new immunotherapy (atezolizumab) plus chemotherapy (FLOT) vs. FLOT alone.
For specific types of stomach or food pipe cancer that are surgically removable.
Treatment is given both before and after surgery.
Open to patients whose cancer shows certain immune-related markers.
It's a Phase 2 study, focused on safety and early effectiveness.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have been diagnosed with stomach cancer or cancer of the food pipe (oesophagus) that has not spread to distant parts of your body and can be surgically removed. Your medical team will confirm that you are fit enough to have surgery and go through the study treatments.

Critically, for this study, your cancer must also show certain markers that suggest your immune system might respond well to the new drug, atezolizumab. These markers are checked using samples of your tumour before you start treatment. If you've already had chemotherapy or targeted treatments for this cancer, or if you've had surgery to remove part of the stomach or food pipe for this cancer before, unfortunately, you wouldn't be able to join.

Women who could become pregnant must agree to use effective birth control during the study and for several months afterward. You also need to be willing and able to follow all the study procedures, including regular appointments and assessments.

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.

Are you 18 years or older?
Do you have stomach cancer or cancer where the food pipe meets the stomach?
Has your doctor confirmed your cancer can be surgically removed and hasn't spread far?
Have you had samples of your cancer checked for specific immune markers?
Have you NOT had previous chemotherapy or targeted treatments for this cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening period of about four weeks. During this time, doctors will do tests and check your cancer samples to make sure you're suitable for the study. If you qualify, you'll be randomly assigned to one of two groups – like drawing lots. You'll either receive the new drug atezolizumab plus FLOT chemotherapy, or FLOT chemotherapy alone.

Both groups will receive treatment before surgery for about 8 weeks (four 2-week cycles). After your surgery, you will continue with treatment. If you are in the atezolizumab plus FLOT group, you will have another 8 weeks of that combination, followed by about 6 months (eight 3-week cycles) of atezolizumab on its own. If you are in the FLOT-alone group, you will have another 8 weeks of FLOT chemotherapy after surgery. The total treatment time, including surgery, will be between approximately 22 to 52 weeks, depending on which group you are in and how your surgery goes. You'll have regular hospital visits for treatments and checks throughout this period.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new treatment combination that isn't yet widely available, and close monitoring of your health. However, there are also potential risks related to the treatments, including side effects from both chemotherapy and immunotherapy. These side effects can vary from person to person. As with any clinical trial, there's no guarantee that the new treatment will be more effective than standard care, or that it will benefit you personally. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

Krankenhaus Nordwest
Verified postcode
Frankfurt, Germany
SAKK Coordinating Center
Verified postcode
Bern, Switzerland

Common questions

What is atezolizumab?

Atezolizumab is a type of immunotherapy that helps your body’s immune system fight cancer cells more effectively.

What does FLOT mean?

FLOT is a standard combination of different chemotherapy drugs used to treat certain stomach cancers. It includes 5-Fluorouracil, Calciumfolinat, Oxaliplatin, and Docetaxel.

What is a 'Phase 2' study?

A Phase 2 study is an earlier stage of research that looks at whether a new treatment is safe and effective enough to be tested in a larger group of people. It helps determine the right dose and identify potential benefits.

Why do you need my tumour sample?

Researchers need your tumour sample to check for specific markers (like MSI-high or PD-L1) which help them identify if your cancer is likely to respond well to the new drug, atezolizumab.

Can I choose which treatment group I'm in?

No, you cannot choose. Participants are randomly assigned to a group (like drawing lots) to make sure the comparison between the treatments is fair and unbiased.