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RecruitingPHASE3INTERVENTIONAL

A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This study is investigating a new way to give a cancer medicine called tislelizumab to people with stomach cancer that has spread or can't be removed by surgery. Currently, tislelizumab is given by a drip into a vein. This study is comparing that to giving it as an injection under the skin, alongside standard chemotherapy. We want to see if the injection method is just as effective and safe, and potentially more convenient for patients. The study involves about 351 patients and is divided into screening, treatment, and follow-up periods. It aims to find the best and most comfortable way to give this important cancer treatment.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
BeOne Medicines
Enrolment target
351
Start
27 Aug 2025
Estimated completion
22 Apr 2028

What is this study about?

This study is about a type of cancer called gastric adenocarcinoma, which is a common form of stomach cancer. It's for people whose stomach cancer has either spread to other parts of the body (metastatic) or is too advanced to be removed with an operation. The study is particularly looking at how a specific cancer drug, called tislelizumab, is given.

Currently, tislelizumab is given through a needle into a vein, like a drip. This study is comparing that method with giving the drug as an injection just under the skin. Both ways will be given alongside standard chemotherapy treatments. The main goal is to see if giving the drug as an injection works just as well as the drip, in terms of how much of the drug gets into the body. If it does, it could be a more convenient and comfortable option for patients.

This is a 'Phase 3' study, which means it's one of the final steps before a new treatment method can be widely used. These studies are very important because they help doctors and patients understand the best ways to treat cancer, aiming for effective treatments that also improve quality of life.

Key takeaways

  • This study is for advanced stomach cancer that cannot be removed by surgery or has spread.
  • It compares two ways of giving the cancer drug tislelizumab: an injection under the skin vs. a drip into a vein.
  • Both methods are given with standard chemotherapy.
  • The aim is to find out if the injection is as effective and safe as the drip, and potentially more convenient.
  • Participation involves regular hospital visits for treatment and monitoring.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, your doctor would need to confirm that you have stomach cancer that cannot be removed by surgery or has spread. You must not have had any previous treatment for this advanced stage of stomach cancer. Doctors will also need to be able to measure your cancer, and you'll need to provide some tissue from your tumour for testing.

There are also some general health requirements, including having generally good health and your body's organs working well. If you are a woman who could get pregnant, or a man who could father a child, you would need to agree to use effective birth control during the study and for several months afterwards.

You would not be able to join if you have certain other types of stomach cancer, active brain tumours that are causing symptoms, or certain autoimmune conditions. Your doctor will check all these detailed criteria to see if this study is right for you.

Quick self-check
  • Do I have stomach cancer that has spread or can't be removed by surgery?
  • Have I already had treatment for this stage of stomach cancer?
  • Am I generally well with good organ function?
  • If I am a man or woman who could have children, am I willing to use effective birth control?
  • Do I have any other severe health problems or certain autoimmune diseases?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it will involve several stages: first, a 'screening period' to check if you're suitable. If you are, you'll then enter a 'treatment period' where you'll receive either the tislelizumab injection under the skin or the drip into a vein, along with standard chemotherapy, for a set amount of time. You'll have regular hospital visits for these treatments, and doctors will monitor your health and how the treatment is working with various tests and assessments.

After your treatment finishes, there will be a 'follow-up period' where your health will continue to be monitored for a longer time, even if you stop taking the study medication. The exact number of visits and the total length of your participation will be explained in detail by the study team, but it will involve regular appointments over a period that could last many months.

Potential risks and benefits

Potential benefits of joining this study could include receiving careful and regular medical attention, and possibly having earlier access to a new way of taking tislelizumab that might be more convenient. However, there's no guarantee the treatment will work for you, or that the new injection method will be better than the standard drip. As with any medical treatment, there are potential risks and side effects, and some might be serious. The study team will explain all known side effects from tislelizumab and chemotherapy. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (93)

  • Ironwood Cancer and Research Centers
    Chandler, United States· Recruiting
  • Cancer and Blood Specialty Clinic
    Los Alamitos, United States· Recruiting
  • UC Health Cancer Care and Hematology Clinic Memorial Hospital Central
    Colorado Springs, United States· Recruiting
  • Bioresearch Partners Holding Hialeah Hospital
    Hialeah, United States· Recruiting
  • Orlando Health Ufhealth Cancer Center
    Orlando, United States· Recruiting
  • Northwestern University
    Chicago, United States· Recruiting
  • Hope and Healing Cancer Services
    Hinsdale, United States· Recruiting
  • University of Kansas Medical Center Research Institute
    Kansas City, United States· Recruiting
  • New England Cancer Specialists
    Westbrook, United States· Recruiting
  • St Louis Cancer Care, Llp
    Bridgeton, United States· Recruiting
  • Nebraska Hematology Oncology
    Lincoln, United States· Recruiting
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, United States· Recruiting

+81 more sites — see the official record for the full list.

Common questions

What is tislelizumab?

Tislelizumab is a cancer medicine that helps your body's immune system fight cancer cells. It's sometimes called an immunotherapy.

What's the difference between an 'injection' and a 'drip'?

An injection (subcutaneous) goes just under the skin, often in the stomach or thigh, and takes a short time. A drip (intravenous) goes into a vein, usually in your arm, and takes longer.

What is 'chemotherapy'?

Chemotherapy uses powerful drugs to kill cancer cells or stop them from growing. In this study, it's given alongside tislelizumab.

How long would I be in the study?

The study involves a screening period, a treatment period, and a follow-up period. The total time can vary, but typically involves many months of treatment and continued monitoring afterwards.

Can I choose if I get the injection or the drip?

No, in this type of study, patients are usually assigned randomly (like drawing lots) to one group or the other to ensure a fair comparison.

How to find out more

BeOne Medicines

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Investigate Tislelizumab Administered as Subcutan…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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