Active not recruitingPHASE2INTERVENTIONAL

Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence

This research study is for people who have had surgery for stomach or where the food pipe joins the stomach cancer. These cancers are considered to have a high chance of returning. The study wants to see if a combination of two immunotherapy drugs, nivolumab and ipilimumab, can keep the cancer from coming back for longer, compared to the usual chemotherapy treatment. Researchers will also look at how safe the new treatment is, how it affects patients' overall health, and their quality of life. This is important to find better ways to help people stay cancer-free after surgery.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrolment target

197

Start

17 Jul 2019

Estimated completion

01 Jun 2026

Gastric and Esophagogastric Junction Adenocarcinoma

What is this study about?

This research study, called a clinical trial, is looking into treating a type of cancer that starts in the stomach or at the point where the food pipe (oesophagus) joins the stomach. These cancers are called adenocarcinoma. The study is for people who have already had an operation to remove their cancer, but who are still at a higher risk of the cancer coming back.

The main goal of the study is to compare two different ways of preventing the cancer from returning: a new treatment using two immunotherapy drugs (nivolumab and ipilimumab) versus the standard chemotherapy treatment. Immunotherapy works by helping your own immune system fight cancer cells. Researchers want to see if this new drug combination can keep the cancer away for longer. They will also be carefully checking how safe the new treatment is and how it affects people's overall well-being and daily life.

Ultimately, this study aims to find out if this immunotherapy combination could be a better option for people with this type of cancer to reduce the chance of it returning after surgery. Finding more effective treatments means more people can live longer, healthier lives free from cancer.

Key takeaways

Compares immunotherapy to chemotherapy for stomach/food pipe cancer.
For patients at high risk of cancer returning after surgery.
Aims to improve cancer-free survival.
Also looking at safety and quality of life.
Requires specific surgery details and good general health.

Who may be eligible?

To be part of this study, you would need to have a specific type of stomach or food pipe cancer (adenocarcinoma) that has been confirmed by tests. You must have already completed your pre-surgery chemotherapy and had an operation to remove the cancer. It's important that you have recovered well from surgery and that the operation happened between two and three months before you might start the study treatment.

The study is for adults aged 18 or over. Your general health, including blood tests and how well your kidneys are working, must be good enough to safely take part in the treatment. Importantly, after your surgery, some cancer cells must have been found in your lymph nodes, or a very small amount of cancer must have been left at the edges of where the tumour was removed (even microscopic).

Your surgeon must have removed at least 15 lymph nodes during your operation. You also need to be well enough to carry out most of your daily activities without much difficulty. A team of doctors will review all these factors to make sure the study is a good fit for you.

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.

Do you have confirmed stomach or food pipe adenocarcinoma?
Have you completed pre-surgery chemotherapy and had your cancer removed by surgery?
Did your surgery for the cancer happen 2 to 3 months ago?
Are you 18 years old or older and in good general health?
Did tests after surgery show cancer cells in your lymph nodes or at the edge of where the tumour was removed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either the new immunotherapy drug combination or standard chemotherapy. This means a computer decides which treatment you get, like flipping a coin. You will have regular hospital visits for your treatment and check-ups. These visits will involve blood tests, physical examinations, and possibly other scans to see how you are responding to the treatment and to monitor for any side effects. You'll also be asked about your quality of life. The exact number and frequency of visits, as well as the total duration of the study treatment and follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in this study could potentially offer a new treatment that might help prevent your cancer from returning, possibly better than current standard treatments. However, like all medications, the study treatments carry potential side effects, which could range from mild to serious. The study team will carefully explain all known risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (28)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Masaryk Memorial Cancer Institute
Verified postcode
Brno, Czechia
University Hospital Hradec Kralove
Verified postcode
Hradec Králové, Czechia
CHRU de Lille - Hopital Huriez
Verified postcode
Lille, France
Hôpital Privé Jean Mermoz
Verified postcode
Lyon, France
Gustave Roussy
Verified postcode
Villejuif, France
Charite - Universitaetsmedizin Berlin
Verified postcode
Berlin, Germany
Kliniken Essen-Mitte
Verified postcode
Essen, Germany
Universitaetsklinikum Freiburg
Verified postcode
Freiburg im Breisgau, Germany
Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
Verified postcode
Hamburg, Germany
SLK-Kliniken Heilbronn
Verified postcode
Heilbronn, Germany
Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden
Verified postcode
Leipzig, Germany
Klinikum Rechts der isar Der Technische Universitaet Muenchen - Klinikum Rechts Der Isar
Verified postcode
München, Germany

Common questions

What is immunotherapy?

Immunotherapy is a type of treatment that helps your body's own immune system find and fight cancer cells more effectively.

What does 'high risk for recurrence' mean?

It means that after your surgery, medical tests showed a higher chance that your cancer might come back in the future.

Will I know which treatment I'm getting?

Because this is a comparative study, you might not know if you're getting the immunotherapy or the standard chemotherapy. This helps researchers get unbiased results.

What is 'quality of life' in this study?

Researchers will ask you questions about how you feel, your daily activities, and your general well-being to understand how the treatment affects your life.

How long will the study last for me?

The total length of time you'll be involved in the study, including treatment and follow-up, will be clearly explained by the study team. It can vary depending on the treatment and how you respond.