Recruiting NCT07043400
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Subcutaneous Tislelizumab, Intravenous Tislelizumab, Cisplatin, Leucovorin.
- Who it may be relevant to
- Registry conditions: Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Austria, Brazil, China +11
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Overview
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.
Detailed description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Interventions
- Drug Subcutaneous Tislelizumab
Administered by subcutaneous injection - Drug Intravenous Tislelizumab
Administered by intravenous infusion - Drug Cisplatin
Administered by intravenous infusion - Drug Leucovorin
Administered by intravenous infusion - Drug 5-fluorouracil (5-FU)
Administered by intravenous infusion - Drug Oxaliplatin
Administered by intravenous infusion - Drug Capecitabine
Administered orally
Primary outcome measures
- Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab [Time frame: 85 Days]
- Model-Predicted Area under the Concentration-time Curve from Time Zero to 21 Days (AUC0-21d) after the First Dose of Tislelizumab [Time frame: 21 Days]
Secondary outcome measures (11)
- Objective Response Rate (ORR) [Time frame: Up to 2 years]
- Progression-Free Survival (PFS) [Time frame: Up to 2 years]
- Duration of Response (DOR) [Time frame: Up to 2 years]
- Disease Control Rate (DCR) [Time frame: Up to 2 years]
- Overall Survival (OS) [Time frame: Up to 2 years]
- Number of Participants With Adverse Events (AEs) [Time frame: Up to 2 years]
- Model-predicted Serum Ctrough at Cycle 1 [Time frame: 21 Days]
- Observed Serum Ctrough at Cycle 1 [Time frame: 21 Days]
- Observed Area Under the Concentration-time Curve at Steady-state (AUC) at Cycle 1 [Time frame: 21 Days]
- Model-predicted Area Under the Concentration-time Curve at Steady-state (AUCss) [Time frame: 85 Days]
- Percentage of Participants with Antidrug Antibodies (ADAs) to Tislelizumab after SC or IV Administration [Time frame: Up to 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 19 centers
- Ironwood Cancer and Research Centers Chandler Ii — Chandler
- Cancer and Blood Specialty Clinic — Los Alamitos
- UC Health Cancer Care and Hematology Clinic Memorial Hospital Central — Colorado Springs
- Bioresearch Partners Holding Hialeah Hospital — Hialeah
- Orlando Health Cancer Institute Downtown Orlando — Orlando
- Northwestern University — Chicago
- Hope and Healing Cancer Services — Hinsdale
- University of Kansas Medical Center Research Institute — Kansas City
- … and 11 more centers
China · 15 centers
- The Second Hospital of Anhui Medical University — Hefei
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- The First Affiliated Hospital of Xiamen University — Xiamen
- Anyang Tumor Hospital — Anyang
- Henan Cancer Hospital — Zhengzhou
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
- Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School — Nanjing
- Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University — Ganzhou
- … and 7 more centers
Brazil · 11 centers
- Hospital de Amor Barretos — Barretos
- CECAP — Blumenau
- Hospital Brasilia — Brasília
- Hospital Universiario Onofre Lopes — Natal
- Hospital Sao Lucas Da Pucrs — Porto Alegre
- IMIP — Recife
- Inca Instituto Nacional de Cancer — Rio de Janeiro
- Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto — São José do Rio Preto
- … and 3 more centers
Japan · 10 centers
- Matsuyama Red Cross Hospital — Matsuyama
- Japan Community Health Care Organization Kyushu Hospital — Kitakyushu
- National Hospital Organization Hokkaido Cancer Center — Sapporo
- Osaka Rosai Hospital — SakaiShi
- Osaka Medical and Pharmaceutical University Hospital — Takatsukishi
- Saitama Cancer Center — Kitaadachigun
- Hamamatsu University School of Medicine, University Hospital — Hamamatsushi
- Tochigi Cancer Center — Utsunomiya
- … and 2 more centers
South Korea · 6 centers
- Seoul National University Bundang Hospital — Seongnam-si
- Kyungpook National University Chilgok Hospital — BukGu
- … and 4 more centers
Czechia · 4 centers
- Masarykuv Onkologicky Ustav — Brno
- Fakultni Nemocnice Hradec Kralove — Hradec Králové
- Fakultni Nemocnice Olomouc — Olomouc
- Vseobecna Fakultni Nemocnice V Praze — Prague
Italy · 4 centers
- Irccs Azienda Ospedaliera Metropolitana (Aom) — Genova
- Fondazione Irccs Istituto Nazionale Dei Tumori — Milan
- Aou Pisana, Stabilimento Di Santa Chiara — Pisa
- Istituto Clinico Humanitas — Rozzano
Spain · 4 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 4 centers
Center list to be confirmed — check the primary protocol.
Argentina · 3 centers
- Hospital Aleman — CABA
- Instituto Alexander Fleming (Iaf) — Ciudad Autonoma Buenos Aires
- Fundacion Cori Para La Investigacion Y Prevencion Del Cancer — La Rioja
France · 3 centers
- Institut Sainte Catherine — Avignon
- Chru de Brest Hopital Cavale Blanche — Brest
- Hopital Claude Huriez Chu Lille — Lille
Mexico · 3 centers
- Health Pharma Professional Research Sa de Cv — Mexico City
- Medical Care and Research Sa de Cv — Mérida
- Centro de Investigacion Clinica de Oaxaca — Oaxaca City
Poland · 3 centers
- Pratia McM Krakow — Krakow
- Opolskie Centrum Onkologii — Opole
- Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie — Warsaw
United Kingdom · 3 centers
Center list to be confirmed — check the primary protocol.
Austria · 2 centers
- Krankenhaus Der Barmherzigen Schwestern Linz — Linz
- Medical Univeristy Vienna — Vienna
Puerto Rico · 1 center
- Pan American Oncology Trials, Llc — Rio Piedras
Identifiers
NCT: NCT07043400 · BGB-A317-316 · 2025-522862-58-00