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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

NCT07043400 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2026-05-11

No results posted yet for this study

Summary

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.

Conditions

  • Metastatic Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

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

Sponsors & Collaborators

  • BeOne Medicines

    lead INDUSTRY

Principal Investigators

  • Study Director · BeOne Medicines

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-27
Primary Completion
2027-10-30
Completion
2028-04-22
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • China
  • Czechia
  • France
  • Italy
  • Japan
  • Poland
  • Puerto Rico
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043400 on ClinicalTrials.gov