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Stomach cancer patients may soon get immunotherapy as a simple shot instead of an IV drip

NCT ID NCT07043400

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 8 times

Summary

This phase 3 trial compares a subcutaneous (under-the-skin) injection of tislelizumab to the standard intravenous (IV) infusion, both given with chemotherapy, as a first treatment for advanced stomach or gastroesophageal junction cancer that cannot be removed by surgery or has spread. About 351 adults will take part. The main goal is to see if the shot provides similar drug levels in the body as the IV, while also checking how well the cancer responds and how long it stays controlled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tislelizumab (a cancer immunotherapy drug) given as a shot under the skin or as an IV drip, plus chemotherapy
What this could lead to
If it works, this could offer a more convenient way to deliver immunotherapy for advanced stomach cancer, possibly with similar effectiveness to the IV version.
What could go wrong
This is an early-stage comparison of drug levels, not a direct test of cure or survival. The shot may not work as well as the IV, and side effects from immunotherapy and chemo can be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 351 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma. * No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. * At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment. * Must be able to provide tumor tissues for biomarker assessment. * Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1. * Adequate organ function. * Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and ≥ 120 days after the last dose of tislelizumab. * Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab. Exclusion Criteria: * Squamous cell or undifferentiated or other histological type gastric cancer (GC) * Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before randomization. * Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2). * Active autoimmune diseases or history of autoimmune diseases that may relapse. * Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to randomization NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroesophageal junction adenocarcinoma Metastatic gastric adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    89 sites in 15 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Acibadem Adana Hospital

    RECRUITING

    Kuruköprü, 01060, Turkey (Türkiye)

  • Affiliated Hospital of Jining Medical University

    RECRUITING

    Jining, Shandong, 272000, China

  • Anyang Tumor Hospital

    RECRUITING

    Anyang, Henan, 455001, China

  • Aou Pisana, Stabilimento Di Santa Chiara

    RECRUITING

    Pisa, 56126, Italy

  • Asan Medical Center

    ACTIVE_NOT_RECRUITING

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Bioresearch Partners Holding Hialeah Hospital

    RECRUITING

    Hialeah, Florida, 33013-3804, United States

  • CECAP

    RECRUITING

    Blumenau, 89035-510, Brazil

  • Cambridge University Hospitals Nhs Foundation Trust

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Cancer Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Cancer and Blood Specialty Clinic

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Centro de Investigacion Clinica de Oaxaca

    RECRUITING

    Oaxaca City, 68020, Mexico

  • Changzhi Peoples Hospital

    RECRUITING

    Changzhi, Shanxi, 046099, China

  • Chru de Brest Hopital Cavale Blanche

    RECRUITING

    Brest, 29200, France

  • Clatterbridge Cancer Centre

    RECRUITING

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • Comprehensive Cancer Centers of Nevada

    RECRUITING

    Las Vegas, Nevada, 89169-3321, United States

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    RECRUITING

    Ankara, 06200, Turkey (Türkiye)

  • Fakultni Nemocnice Hradec Kralove

    RECRUITING

    Hradec Králové, 500 03, Czechia

  • Fakultni Nemocnice Olomouc

    RECRUITING

    Olomouc, 77900, Czechia

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    RECRUITING

    São José do Rio Preto, 15090-000, Brazil

  • Fundacion Cori Para La Investigacion Y Prevencion Del Cancer

    RECRUITING

    La Rioja, F5300COE, Argentina

  • Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University

    RECRUITING

    Ganzhou, Jiangxi, 341000, China

  • Hamamatsu University School of Medicine, University Hospital

    RECRUITING

    Hamamatsushi, Shizuoka, 431-3192, Japan

  • Health Pharma Professional Research Sa de Cv

    RECRUITING

    Mexico City, 03100, Mexico

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Hope and Healing Cancer Services

    RECRUITING

    Hinsdale, Illinois, 60521-0509, United States

  • Hopital Claude Huriez Chu Lille

    RECRUITING

    Lille, 59000, France

  • Hospital Aleman

    RECRUITING

    Caba, 1425, Argentina

  • Hospital Brasilia

    RECRUITING

    Brasília, 71681-603, Brazil

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Santa Rita de Cassia Afecc

    RECRUITING

    Vitória, 29043-260, Brazil

  • Hospital Sao Lucas Da Pucrs

    RECRUITING

    Porto Alegre, 90610-000, Brazil

  • Hospital Universiario Onofre Lopes

    RECRUITING

    Natal, 59012-300, Brazil

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Hospital de Amor Barretos

    RECRUITING

    Barretos, 14784-400, Brazil

  • Hunterdon Hematology Oncology

    RECRUITING

    Flemington, New Jersey, 08822-4603, United States

  • IMIP

    RECRUITING

    Recife, 50070-902, Brazil

  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

    RECRUITING

    São Paulo, 01246-000, Brazil

  • Inca Instituto Nacional de Cancer

    RECRUITING

    Rio de Janeiro, 20231-050, Brazil

  • Institut Sainte Catherine

    RECRUITING

    Avignon, 84000, France

  • Institute of Science Tokyo Hospital

    RECRUITING

    Bunkyoku, Tokyo, 113-8519, Japan

  • Instituto Alexander Fleming (Iaf)

    RECRUITING

    Ciudad Autonoma Buenos Aires, 1426, Argentina

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    RECRUITING

    São Paulo, 01401-004, Brazil

  • Irccs Azienda Ospedaliera Metropolitana (Aom)

    RECRUITING

    Genova, 16132, Italy

  • Ironwood Cancer and Research Centers Chandler Ii

    RECRUITING

    Chandler, Arizona, 85224-5665, United States

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, 20089, Italy

  • Japan Community Health Care Organization Kyushu Hospital

    RECRUITING

    Kitakyushu, Fukuoka, 806-0034, Japan

  • Krankenhaus Der Barmherzigen Schwestern Linz

    RECRUITING

    Linz, 4010, Austria

  • Kyungpook National University Chilgok Hospital

    ACTIVE_NOT_RECRUITING

    BukGu, Gyeongsangbukdo, 41404, South Korea

  • Masarykuv Onkologicky Ustav

    RECRUITING

    Brno, 602 00, Czechia

  • Matsuyama Red Cross Hospital

    RECRUITING

    Matsuyama, Ehime, 790 8524, Japan

  • Medical Care and Research Sa de Cv

    RECRUITING

    Mérida, 97070, Mexico

  • Medical Park Florya Hospital

    RECRUITING

    Sefaköy, 34295, Turkey (Türkiye)

  • Medical Park Seyhan Hospital

    RECRUITING

    Adana, 01060, Turkey (Türkiye)

  • Medical Univeristy Vienna

    RECRUITING

    Vienna, 1090, Austria

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie

    RECRUITING

    Warsaw, 02-781, Poland

  • National Hospital Organization Hokkaido Cancer Center

    RECRUITING

    Sapporo, Hokkaido, 003-0804, Japan

  • Nebraska Hematology Oncology

    RECRUITING

    Lincoln, Nebraska, 68506-7548, United States

  • New England Cancer Specialists

    RECRUITING

    Westbrook, Maine, 04092, United States

  • Ninewells Hospital and Medical School

    RECRUITING

    Dundee, DD1 9SY, United Kingdom

  • Northwest Medical Specialties

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Opolskie Centrum Onkologii

    RECRUITING

    Opole, 45-061, Poland

  • Oregon Oncology Specialists

    RECRUITING

    Salem, Oregon, 97301, United States

  • Orlando Health Cancer Institute Downtown Orlando

    RECRUITING

    Orlando, Florida, 32806, United States

  • Osaka Medical and Pharmaceutical University Hospital

    RECRUITING

    Takatsukishi, Osaka, 569-8686, Japan

  • Osaka Rosai Hospital

    RECRUITING

    SakaiShi, Osaka, 591-8025, Japan

  • Pan American Oncology Trials, Llc

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • Pratia McM Krakow

    RECRUITING

    Krakow, 30-727, Poland

  • Saitama Cancer Center

    RECRUITING

    Kitaadachigun, Saitama, 362-0806, Japan

  • Samsung Medical Center

    ACTIVE_NOT_RECRUITING

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Scott and White Memorial Hospital

    RECRUITING

    Temple, Texas, 76508-0001, United States

  • Seoul National University Bundang Hospital

    ACTIVE_NOT_RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    ACTIVE_NOT_RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    ACTIVE_NOT_RECRUITING

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shanxi Provincial Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, 030013, China

  • St Louis Cancer Care, Llp

    RECRUITING

    Bridgeton, Missouri, 63044, United States

  • Summit Medical Group

    RECRUITING

    Florham Park, New Jersey, 07932-1049, United States

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110001, China

  • The Second Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230601, China

  • The University of Texas Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-4009, United States

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

  • Tochigi Cancer Center

    RECRUITING

    Utsunomiya, Tochigi, 320-0834, Japan

  • Tokyo Metropolitan Bokutoh Hospital

    RECRUITING

    SumidaKu, Tokyo, 130-8575, Japan

  • UC Health Cancer Care and Hematology Clinic Memorial Hospital Central

    RECRUITING

    Colorado Springs, Colorado, 80909, United States

  • University of Kansas Medical Center Research Institute

    RECRUITING

    Kansas City, Kansas, 66160-8500, United States

  • Vanderbilt University

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Vseobecna Fakultni Nemocnice V Praze

    RECRUITING

    Prague, 10000, Czechia

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