A study comparing injection under the skin versus infusion into the vein of tislelizumab with chemotherapy for patients with advanced gastric or gastroesophageal junction cancer

3 1 1 1

What is this study about?

This study involves patients with gastric or gastroesophageal junction adenocarcinoma, which is a type of cancer that affects the stomach or the area where the esophagus meets the stomach. The cancer being studied is either locally advanced and cannot be removed by surgery, or it has spread to other parts of the body. The treatment being tested is tislelizumab, which is also known by its code name BGB-A317 and is marketed as Tevimbra. This medication will be given together with chemotherapy, which is a standard cancer treatment that uses drugs to kill cancer cells. The study compares two different ways of giving tislelizumab: one method involves injecting the medication under the skin using a subcutaneous injection, while the other method involves giving it directly into a vein through an intravenous infusion.

The purpose of this study is to find out whether tislelizumab given as an injection under the skin reaches the same levels in the body as when it is given through a vein, and to see if the injection under the skin is as safe and effective as the intravenous method. The study will measure the amount of medication in the blood at different times and compare the results between the two groups. Researchers will also look at how well the treatment works by checking whether tumors shrink or stop growing, how long patients live without their cancer getting worse, and how long the treatment keeps working.

During the study, patients will receive tislelizumab in one of the two ways mentioned, along with chemotherapy, as their first treatment for this type of advanced cancer. The treatment can continue for up to 24 months. Throughout the study, doctors will monitor patients for any side effects and collect information about how the cancer responds to treatment. Patients will need to provide tumor tissue samples for testing, and the study will also check whether the body develops any immune responses against the medication.

1 Treatment assignment

Upon joining the study, you will be randomly assigned to one of two treatment groups. This means that neither you nor your doctor will choose which group you are in.

One group will receive tislelizumab as a subcutaneous injection, which means the medication will be injected under the skin. The other group will receive tislelizumab as an intravenous infusion, which means the medication will be given directly into a vein over a period of time.

Both groups will also receive chemotherapy in combination with tislelizumab.

2 Treatment cycles

The treatment will be given in cycles. Each cycle lasts 21 days (3 weeks).

On Day 1 of each cycle, you will receive tislelizumab either as a subcutaneous injection or as an intravenous infusion, depending on which group you were assigned to.

You will also receive chemotherapy according to the schedule determined by your treatment plan.

This treatment pattern will continue for multiple cycles as long as the treatment is working and you are not experiencing unacceptable side effects.

3 Monitoring and assessments

Throughout the study, your health will be monitored regularly to check how the treatment is affecting you and whether it is working.

Blood samples will be taken at specific times to measure the levels of tislelizumab in your body. One important measurement will be taken before your dose on Day 1 of Cycle 5.

Your tumor will be assessed using imaging scans to see if it is responding to the treatment. These assessments will follow standard guidelines called RECIST version 1.1, which is a set of rules used to measure tumor response.

You will need to provide tumor tissue samples for laboratory testing to help understand how the treatment works.

4 Safety monitoring

Your doctor will monitor you for any side effects or adverse events throughout the study. This includes both mild and serious side effects.

Any side effects will be recorded and assessed for their severity, when they occur, and whether they are related to the study treatment.

Tests will be performed to check your organ function, including your liver, kidneys, and blood cells, to ensure your body is tolerating the treatment.

Blood tests will also be done to check if your body has developed any antidrug antibodies, which are proteins your immune system might make in response to tislelizumab.

5 Birth control requirements

If you are a woman who can become pregnant, you must use a highly effective method of birth control throughout the entire study period.

You must continue using birth control for at least 120 days after receiving your last dose of tislelizumab.

If you are a male who is not sterile, you must also use a highly effective method of birth control during the study and for at least 120 days after your last dose of tislelizumab.

6 Study duration

The length of time you will receive treatment depends on how well the treatment is working for you and how well you are tolerating it.

Even after your treatment ends, you will continue to be followed for safety monitoring and to assess long-term outcomes.

The overall study is expected to continue until approximately April 2028, though your individual participation may be shorter or longer depending on your specific situation.

Who Can Join the Study?

  • You must have gastric cancer (cancer of the stomach) or gastroesophageal junction cancer (cancer where the food pipe meets the stomach) that has been confirmed by examining tissue under a microscope. This cancer must have spread to other parts of the body or grown locally in a way that cannot be removed by surgery.
  • You must not have received any previous treatment with medicines given through the bloodstream for your cancer that has spread or cannot be removed by surgery.
  • You must have at least one tumor that can be measured or seen on scans according to a set of rules called RECIST v1.1, which are guidelines doctors use to measure tumors.
  • You must be able to provide samples of your tumor tissue so that doctors can study certain characteristics of your cancer.
  • Your general health and ability to carry out daily activities must be good, with a score of 1 or less on a scale called ECOG Performance Status. This means you can do light work and take care of yourself with little or no limitations.
  • Your organs, including your liver, kidneys, and bone marrow, must be working well enough based on blood tests and other measurements.
  • If you are a woman who can become pregnant, you must agree to use a very reliable method of birth control (contraception) during the entire study and for at least 120 days after receiving the last dose of the study medicine.
  • If you are a man who can father children, you must agree to use a very reliable method of birth control (contraception) during the entire study and for at least 120 days after receiving the last dose of the study medicine.

Who Cannot Join the Study?

  • The study information provided does not contain specific reasons why patients cannot participate in this clinical trial
  • Please note that exclusion criteria are specific conditions or factors that would prevent someone from joining a study, but these details were not included in the available study information
  • Typical exclusion criteria in clinical trials may include other serious medical conditions, certain medications being taken, or previous treatments, but without the specific information for this study, these cannot be listed

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
Pratia S.A. Skorzewo Poland
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opole Poland
Institut Sainte Catherine Avignon France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Oqasfauibpouce Lnsu Gdjx Linz Austria
Nhxnyyqn Iovzidwk Oohsamemq Ieg Miosy Scedkuntetxvdgzoszskbehityts Ianccrty Bgxwgcla Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.12.2025
Czechia Czechia
Recruiting
01.12.2025
France France
Recruiting
01.12.2025
Italy Italy
Recruiting
01.12.2025
Poland Poland
Not yet recruiting
01.12.2025
Spain Spain
Recruiting
01.12.2025

Trial locations

Investigated drugs:

Tislelizumab is a type of cancer treatment that helps your immune system fight cancer cells. In this study, it will be given in two different ways: either as an injection under the skin or through a vein, along with chemotherapy medicines. This medication is being tested as a treatment for people with advanced stomach cancer or cancer at the place where the esophagus joins the stomach.

Chemotherapy refers to cancer-fighting medicines that work by killing fast-growing cells in your body, including cancer cells. In this study, chemotherapy will be given together with tislelizumab to help treat the cancer.

Gastric Adenocarcinoma – Gastric adenocarcinoma is a type of cancer that develops in the stomach lining from glandular cells. The disease begins when normal cells in the stomach start to grow abnormally and form a tumor. As the cancer progresses, it can grow deeper into the layers of the stomach wall. In advanced stages, the tumor may spread beyond the stomach to nearby organs and tissues. When the disease becomes metastatic, cancer cells travel through the bloodstream or lymphatic system to distant parts of the body. Locally advanced unresectable gastric adenocarcinoma refers to tumors that have grown extensively but cannot be removed by surgery.

Gastroesophageal Junction Adenocarcinoma – Gastroesophageal junction adenocarcinoma is a cancer that develops at the area where the esophagus meets the stomach. This tumor arises from glandular cells located at this junction point. The cancer can grow into the walls of either the lower esophagus or upper stomach. As it advances, the tumor may extend to surrounding tissues and become difficult to remove surgically. The disease can progress to a metastatic stage where cancer cells spread to lymph nodes and distant organs. This type of cancer shares characteristics with both esophageal and gastric cancers due to its location.

Trial ID:
2025-522862-58-00
Protocol code:
BGB-A317-316
NCT ID:
NCT07043400
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Evaluation of Safety and Efficacy of MK-2870 and Paclitaxel in Second-Line Treatment of Advanced/Metastatic Gastroesophageal Adenocarcinoma

    Recruiting

    1 1 1 1
    France Germany Italy Norway
  • A study to evaluate the use of [68Ga]BED003 for imaging colorectal, gastric, pancreatic, breast, and ovarian cancers.

    Recruiting

    2 1 1
    Investigated diseases:
    Italy The Netherlands