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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab [Срок оценки: 85 Days]
• Model-Predicted Area under the Concentration-time Curve from Time Zero to 21 Days (AUC0-21d) after the First Dose of Tislelizumab [Срок оценки: 21 Days]

Вторичные конечные точки (11)

• Objective Response Rate (ORR) [Срок оценки: Up to 2 years]
• Progression-Free Survival (PFS) [Срок оценки: Up to 2 years]
• Duration of Response (DOR) [Срок оценки: Up to 2 years]
• Disease Control Rate (DCR) [Срок оценки: Up to 2 years]
• Overall Survival (OS) [Срок оценки: Up to 2 years]
• Number of Participants With Adverse Events (AEs) [Срок оценки: Up to 2 years]
• Model-predicted Serum Ctrough at Cycle 1 [Срок оценки: 21 Days]
• Observed Serum Ctrough at Cycle 1 [Срок оценки: 21 Days]
• Observed Area Under the Concentration-time Curve at Steady-state (AUC) at Cycle 1 [Срок оценки: 21 Days]
• Model-predicted Area Under the Concentration-time Curve at Steady-state (AUCss) [Срок оценки: 85 Days]
• Percentage of Participants with Antidrug Antibodies (ADAs) to Tislelizumab after SC or IV Administration [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 19 центров

• 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
• … и ещё 11 центров

Китай · 15 центров

• The Second Hospital of Anhui Medical University — Хэфэй
• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• The First Affiliated Hospital of Xiamen University — Xiamen
• Anyang Tumor Hospital — Anyang
• Henan Cancer Hospital — Чжэнчжоу
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School — Нанкин
• Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University — Ganzhou
• … и ещё 7 центров

Бразилия · 11 центров

• 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
• … и ещё 3 центра

Япония · 10 центров

• 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
• … и ещё 2 центра

South Korea · 6 центров

• Seoul National University Bundang Hospital — Seongnam-si
• Kyungpook National University Chilgok Hospital — BukGu
• … и ещё 4 центра

Чехия · 4 центра

• Masarykuv Onkologicky Ustav — Brno
• Fakultni Nemocnice Hradec Kralove — Hradec Králové
• Fakultni Nemocnice Olomouc — Olomouc
• Vseobecna Fakultni Nemocnice V Praze — Prague

Италия · 4 центра

• Irccs Azienda Ospedaliera Metropolitana (Aom) — Genova
• Fondazione Irccs Istituto Nazionale Dei Tumori — Milan
• Aou Pisana, Stabilimento Di Santa Chiara — Pisa
• Istituto Clinico Humanitas — Rozzano

Испания · 4 центра

Список центров уточняется — проверьте первичный протокол.

Turkey (Türkiye) · 4 центра

Список центров уточняется — проверьте первичный протокол.

Аргентина · 3 центра

• Hospital Aleman — CABA
• Instituto Alexander Fleming (Iaf) — Ciudad Autonoma Buenos Aires
• Fundacion Cori Para La Investigacion Y Prevencion Del Cancer — La Rioja

Франция · 3 центра

• Institut Sainte Catherine — Avignon
• Chru de Brest Hopital Cavale Blanche — Brest
• Hopital Claude Huriez Chu Lille — Lille

Мексика · 3 центра

• 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

Польша · 3 центра

• Pratia McM Krakow — Krakow
• Opolskie Centrum Onkologii — Opole
• Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie — Warsaw

Великобритания · 3 центра

Список центров уточняется — проверьте первичный протокол.

Австрия · 2 центра

• Krankenhaus Der Barmherzigen Schwestern Linz — Linz
• Medical Univeristy Vienna — Vienna

Пуэрто-Рико · 1 центр

• Pan American Oncology Trials, Llc — Rio Piedras

Идентификаторы

NCT: NCT07043400 · BGB-A317-316 · 2025-522862-58-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗