Study on Tislelizumab Plus Chemotherapy for Advanced Gastric or Esophageal Cancer in Minority Patients in the U.S.

Sponsor: BeOne Medicines

Sponsor score: 0

ClinicalTrials ID:NCT07554521

Provider View

This clinical trial is testing the effects of a new treatment combining the drug Tislelizumab with chemotherapy in minority patients in the U.S. who have advanced gastric or esophageal cancer that cannot be removed by surgery or has spread to other parts of the body.

Patient Parameters

Program Overview

The aim of this study is to understand how well the drug Tislelizumab works when combined with chemotherapy in treating advanced gastric or esophageal cancer in minority patients in the U.S. The study will focus on patients whose cancer is HER2-negative and PD-L1-positive, meaning their tumors have specific markers that the treatment targets. The study will last up to 6 years to gather comprehensive data on the treatment's effects and safety.

Eligibility Criteria

Inclusion Criteria

  • Identify as a member of a racial or ethnic minority group, such as Black, Hispanic, Native American, or Pacific Islander.
  • Have a confirmed diagnosis of advanced gastric or gastroesophageal cancer or esophageal squamous cell carcinoma that cannot be surgically removed or has spread.
  • Have not received any previous treatment for this advanced cancer.
  • Have at least one tumor that can be measured by scans.
  • Have a tumor that tests positive for the PD-L1 marker.
  • Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function based on recent lab tests.
  • Women of childbearing age must agree to use effective birth control during the study and for a specified period after the last dose of treatment.
  • Men must agree to use effective birth control during the study and for a specified period after the last dose of treatment.

Exclusion Criteria

  • Have a different type of gastric cancer than those being studied.
  • Have active or uncontrolled cancer that has spread to the brain or spinal cord.
  • Have certain conditions affecting the esophagus that cannot be treated.
  • Have gastric cancer that is HER2-positive.
  • Have active autoimmune diseases or a history of autoimmune diseases that may relapse, except for certain controlled conditions like Type I diabetes or hypothyroidism.
  • Have had another active cancer within the last 2 years, except for certain treated cancers.
  • Have uncontrollable fluid buildup around the lungs, heart, or abdomen.
  • Have significant bleeding from the digestive tract within the last month.
  • Have a history of serious gastrointestinal issues like perforation or fistulae within the last 6 months.
  • Have a significant bowel obstruction.
  • Have needed systemic treatment with corticosteroids or other immunosuppressive medications within the last 14 days.

Locations

FACILITYZIPCITYSTATE
Bioresearch Partners Holding Hialeah Hospital33013-3804HialeahFlorida

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