RecruitingPHASE2INTERVENTIONAL

A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma

This research study, called GEMINI-PeriOp GC, is exploring new ways to treat a type of cancer affecting the stomach, where the food pipe joins the stomach, or the food pipe itself. This cancer can usually be removed with surgery. The study will test new medications or combinations of existing drugs. Doctors want to understand how safe these new treatments are, how the body handles them, and if they show early signs of shrinking the cancer. The medicines will be given both before and after surgery. It's for people who haven't had treatment for this cancer before. This is a Phase II study, meaning it's an early stage of testing new treatments.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

AstraZeneca

Enrolment target

100

Start

17 Jul 2025

Estimated completion

06 Sep 2028

Gastroesophageal Adenocarcinoma

What is this study about?

This study is investigating new treatments for a specific type of cancer that can be found in the stomach or the tube that carries food from your throat to your stomach (doctors call this the oesophagus or oesophageal junction). When doctors say "locally advanced resectable," it means the cancer has grown a bit but can still be taken out with an operation. The main goal is to find better ways to treat this cancer both before and after surgery.

The study will look at several new drugs or mixes of drugs. The doctors want to learn if these treatments are safe for people, how they work in the body, and if they help to shrink the cancer. Trying new treatments is important because it helps improve care for people with cancer in the future. This study is organised into different groups, called sub-studies, which allow doctors to test various new treatments at the same time.

Participants will be placed into one of these sub-studies. Each sub-study will focus on a different new drug or drug combination. Before starting, experts will make sure the proposed amount of medicine is safe. These new approaches aim to offer more options and potentially better outcomes for patients facing this type of cancer.

Key takeaways

This study is for stomach or food pipe cancer that can be surgically removed.
It tests new drugs or drug combinations given before and after surgery.
The goal is to check safety and early signs of effectiveness.
You will be closely monitored with regular tests and scans.
Participation is for adults aged 18 and over, of any sex.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you would generally need to have a confirmed diagnosis of stomach, oesophageal junction, or oesophageal cancer that doctors believe can be removed with surgery. You also need to be fit enough for the study, usually meaning you can do most of your daily activities without much trouble.

Your cancer would also need to meet certain genetic markers. For example, some sub-studies might require your cancer to have specific protein markers (like CLDN18.2-positive and HER2-negative, or HER2-positive). Your body's organs, like your kidneys and liver, and your blood counts, need to be working well.

There are also reasons why you might not be able to join. These include having had any past cancer treatment for this specific cancer, having certain long-term illnesses like severe autoimmune diseases, or if the cancer has spread to other parts of your body. Having serious heart conditions, uncontrolled infections, or certain lung conditions would also typically prevent you from joining. The study is for adults aged 18 and older, and welcomes both men and women.

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 stomach or food pipe cancer that doctors say can be operated on?
Have you started any treatment for this cancer yet?
Are you generally feeling well and can manage most daily activities?
Have you ever been told you have an autoimmune disease that needs strong medicines (like steroids)?
Does your doctor know if your cancer has specific markers like CLDN18.2 or HER2?
Are you 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either a new drug or a new combination of drugs both before and after your surgery for cancer. The study involves regular visits to the hospital for assessments. These will include blood tests, health checks, and scans to see how your body is responding to the treatment and to monitor the cancer. The specific schedule of visits and tests will depend on which treatment group you are in. You will stay on the study treatment for a period before your surgery, and then likely continue with a different part of the treatment after your surgery. There will be ongoing follow-up appointments to check on your health even after the main treatment phases are complete. The total duration of your participation, including follow-up, will be explained fully by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as gaining access to new treatments before they are widely available. You would also be closely monitored by a healthcare team. However, with any new treatment, there are potential risks, including side effects from the medications. These side effects can vary and will be explained in detail by the study team. It's important to remember that this is a research study, and there's no guarantee the treatment will work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (70)

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

Research Site
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Newark, United States· Recruiting
Research Site
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Washington D.C., United States· Recruiting
Research Site
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Fairway, United States· Recruiting
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North Shores, United States· Recruiting
Research Site
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New York, United States· Not yet recruiting
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New York, United States· Recruiting
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Pittsburgh, United States· Not yet recruiting
Research Site
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Toronto, Canada· Suspended
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Montreal, Canada· Recruiting
Research Site
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Montreal, Canada· Recruiting
Research Site
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Beijing, China· Recruiting
Research Site
Verified postcode
Changchun, China· Recruiting

Common questions

What is 'locally advanced resectable' cancer?

It means the cancer has grown a bit but doctors believe they can still completely remove it with an operation.

What does 'perioperative treatment' mean?

It refers to treatment given both before and after surgery to help improve the outcome.

What kind of conditions can prevent me from joining?

Things like having had previous cancer treatment for this specific cancer, certain long-term health issues like severe autoimmune diseases, or if your cancer has spread beyond the local area.

Are the treatments new?

Yes, this study is testing new drugs or new combinations of existing drugs. It's an early-stage study (Phase II) to see how well they work and how safe they are.

Will I know which treatment I'm getting?

Yes, because this is an 'open-label' study, you and your doctors will know which specific treatment you are receiving.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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