RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-08-27
Study Completion:2028-04-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07043400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma.
  2. * No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.
  3. * At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.
  4. * Must be able to provide tumor tissues for biomarker assessment.
  5. * Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.
  6. * Adequate organ function.
  7. * 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.
  8. * 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.
  1. * Squamous cell or undifferentiated or other histological type gastric cancer (GC)
  2. * 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.
  3. * Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).
  4. * Active autoimmune diseases or history of autoimmune diseases that may relapse.
  5. * Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to randomization

Contacts and Locations

Study Contact

BeiGene
CONTACT
1-877-828-5568
ClinicalTrials@beigene.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

Ironwood Cancer and Research Centers
Chandler, Arizona, 85224-5665
United States
City of Hope National Medical Center
Duarte, California, 91010-3012
United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720-3302
United States
University of Colorado Health Memorial Hospital
Colorado Springs, Colorado, 80909-4501
United States
Bioresearch Partners Holding Hialeah Hospital
Hialeah, Florida, 33013-3804
United States
Orlando Health Ufhealth Cancer Center
Orlando, Florida, 32806-2134
United States
Northwestern University
Chicago, Illinois, 60611
United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521-0509
United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160-8500
United States
New England Cancer Specialists
Westbrook, Maine, 04092
United States
Nebraska Hematology Oncology
Lincoln, Nebraska, 68506-7548
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169-3321
United States
Hunterdon Hematology Oncology
Flemington, New Jersey, 08822-4603
United States
Summit Medical Group
Florham Park, New Jersey, 07932-1049
United States
Oregon Oncology Specialists
Salem, Oregon, 97301
United States
Vanderbilt University
Nashville, Tennessee, 37232
United States
Md Anderson Cancer Center
Houston, Texas, 77030-3907
United States
Scott and White Memorial Hospital
Temple, Texas, 76508-0001
United States
Northwest Medical Specialties
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-27
Study Completion Date2028-04-22

Study Record Updates

Study Start Date2025-08-27
Study Completion Date2028-04-22

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma