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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: BeOne Medicines • ClinicalTrials.gov ID: NCT07043400

Registry updated: 2026-10-14
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Description

This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment period, and a follow-up period.

Interventions

  • Subcutaneous Tislelizumab (Drug)
    Administered by subcutaneous injection
  • Intravenous Tislelizumab (Drug)
    Administered by intravenous infusion
  • Cisplatin (Drug)
    Administered by intravenous infusion
  • Leucovorin (Drug)
    Administered by intravenous infusion
  • 5-fluorouracil (5-FU) (Drug)
    Administered by intravenous infusion
  • Oxaliplatin (Drug)
    Administered by intravenous infusion
  • Capecitabine (Drug)
    Administered orally

Eligibility criteria

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.

Conditions

Metastatic Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

Locations

  • Ironwood Cancer and Research Centers Chandler Ii — Chandler, Arizona, United States
  • Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
  • UC Health Cancer Care and Hematology Clinic Memorial Hospital Central — Colorado Springs, Colorado, United States
  • Bioresearch Partners Holding Hialeah Hospital — Hialeah, Florida, United States
  • Orlando Health Cancer Institute Downtown Orlando — Orlando, Florida, United States
  • Northwestern University — Chicago, Illinois, United States
  • Hope and Healing Cancer Services — Hinsdale, Illinois, United States
  • University of Kansas Medical Center Research Institute — Kansas City, Kansas, United States
  • New England Cancer Specialists — Westbrook, Maine, United States
  • St Louis Cancer Care, Llp — Bridgeton, Missouri, United States
  • Nebraska Hematology Oncology — Lincoln, Nebraska, United States
  • Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
  • Hunterdon Hematology Oncology — Flemington, New Jersey, United States
  • Summit Medical Group — Florham Park, New Jersey, United States
  • Oregon Oncology Specialists — Salem, Oregon, United States
  • Vanderbilt University — Nashville, Tennessee, United States
  • The University of Texas Md Anderson Cancer Center — Houston, Texas, United States
  • Baylor Scott and White Medical Center Temple — Temple, Texas, United States
  • Northwest Medical Specialties — Tacoma, Washington, United States
  • Hospital Aleman — Caba, Argentina
  • Instituto Alexander Fleming (Iaf) — Ciudad Autonoma Buenos Aires, Argentina
  • Fundacion Cori Para La Investigacion Y Prevencion Del Cancer — La Rioja, Argentina
  • Krankenhaus Der Barmherzigen Schwestern Linz — Linz, Austria
  • Medical Univeristy Vienna — Vienna, Austria
  • Hospital de Amor Barretos — Barretos, Brazil
  • CECAP — Blumenau, Brazil
  • Hospital Brasilia — Brasília, Brazil
  • Hospital Universiario Onofre Lopes — Natal, Brazil
  • Hospital Sao Lucas Da Pucrs — Porto Alegre, Brazil
  • IMIP — Recife, Brazil
  • Inca Instituto Nacional de Cancer — Rio de Janeiro, Brazil
  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto — São José do Rio Preto, Brazil
  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira — São Paulo, Brazil
  • Instituto Dor de Pesquisa E Ensino Sao Paulo — São Paulo, Brazil
  • Hospital Santa Rita de Cassia Afecc — Vitória, Brazil
  • The Second Hospital of Anhui Medical University — Hefei, Anhui, China
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
  • The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
  • Anyang Tumor Hospital — Anyang, Henan, China
  • Henan Cancer Hospital — Zhengzhou, Henan, China
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China
  • Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University — Ganzhou, Jiangxi, China
  • The First Hospital of China Medical University — Shenyang, Liaoning, China
  • Shandong Cancer Hospital — Jinan, Shandong, China
  • Affiliated Hospital of Jining Medical University — Jining, Shandong, China
  • Changzhi Peoples Hospital — Changzhi, Shanxi, China
  • Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China
  • The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
  • Masarykuv Onkologicky Ustav — Brno, Czechia
  • Fakultni Nemocnice Hradec Kralove — Hradec Králové, Czechia
  • Fakultni Nemocnice Olomouc — Olomouc, Czechia
  • Vseobecna Fakultni Nemocnice V Praze — Prague, Czechia
  • Institut Sainte Catherine — Avignon, France
  • Chru de Brest Hopital Cavale Blanche — Brest, France
  • Hopital Claude Huriez Chu Lille — Lille, France
  • Irccs Azienda Ospedaliera Metropolitana (Aom) — Genova, Italy
  • Fondazione Irccs Istituto Nazionale Dei Tumori — Milan, Italy
  • Aou Pisana, Stabilimento Di Santa Chiara — Pisa, Italy
  • Istituto Clinico Humanitas — Rozzano, Italy
  • Matsuyama Red Cross Hospital — Matsuyama, Ehime, Japan
  • Japan Community Health Care Organization Kyushu Hospital — Kitakyushu, Fukuoka, Japan
  • National Hospital Organization Hokkaido Cancer Center — Sapporo, Hokkaido, Japan
  • Osaka Rosai Hospital — SakaiShi, Osaka, Japan
  • Osaka Medical and Pharmaceutical University Hospital — Takatsukishi, Osaka, Japan
  • Saitama Cancer Center — Kitaadachigun, Saitama, Japan
  • Hamamatsu University School of Medicine, University Hospital — Hamamatsushi, Shizuoka, Japan
  • Tochigi Cancer Center — Utsunomiya, Tochigi, Japan
  • Institute of Science Tokyo Hospital — Bunkyoku, Tokyo, Japan
  • Tokyo Metropolitan Bokutoh Hospital — SumidaKu, Tokyo, Japan
  • Health Pharma Professional Research Sa de Cv — Mexico City, Mexico
  • Medical Care and Research Sa de Cv — Mérida, Mexico
  • Centro de Investigacion Clinica de Oaxaca — Oaxaca City, Mexico
  • Pratia McM Krakow — Krakow, Poland
  • Opolskie Centrum Onkologii — Opole, Poland
  • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie — Warsaw, Poland
  • Pan American Oncology Trials, Llc — Rio Piedras, Puerto Rico
  • Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
  • Kyungpook National University Chilgok Hospital — BukGu, Gyeongsangbukdo, South Korea
  • Samsung Medical Center — GangnamGu, Seoul Teugbyeolsi, South Korea
  • Severance Hospital Yonsei University Health System — SeodaemunGu, Seoul Teugbyeolsi, South Korea
  • Seoul National University Hospital — Seoul, Seoul Teugbyeolsi, South Korea
  • Asan Medical Center — SongpaGu, Seoul Teugbyeolsi, South Korea
  • Hospital Clinic de Barcelona — Barcelona, Spain
  • Hospital Universitario de Navarra — Pamplona, Spain
  • Hospital Clinico Universitario de Valencia — Valencia, Spain
  • Hospital Universitario Miguel Servet — Zaragoza, Spain
  • Medical Park Seyhan Hospital — Adana, Turkey (Türkiye)
  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital — Ankara, Turkey (Türkiye)
  • Acibadem Adana Hospital — Kuruköprü, Turkey (Türkiye)
  • Medical Park Florya Hospital — Sefaköy, Turkey (Türkiye)
  • Cambridge University Hospitals Nhs Foundation Trust — Cambridge, United Kingdom
  • Ninewells Hospital and Medical School — Dundee, United Kingdom
  • Clatterbridge Cancer Centre — Metropolitan Borough of Wirral, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record