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RECRUITING Phase 3

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 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Cisplatin
  • DRUG Leucovorin
  • DRUG Subcutaneous Tislelizumab
  • DRUG Intravenous Tislelizumab
  • DRUG 5-fluorouracil (5-FU)

Study Locations (20)

Other

  • Krankenhaus Der Barmherzigen Schwestern Linz — Linz
  • Hospital de Amor Barretos — Barretos
  • CECAP — Blumenau

Florida

  • Bioresearch Partners Holding Hialeah Hospital — Hialeah
  • Orlando Health Ufhealth Cancer Center — Orlando

Illinois

  • Northwestern University — Chicago
  • Hope and Healing Cancer Services — Hinsdale

New Jersey

  • Hunterdon Hematology Oncology — Flemington
  • Summit Medical Group — Florham Park

Texas

  • Md Anderson Cancer Center — Houston
  • Scott and White Memorial Hospital — Temple

Arizona

  • Ironwood Cancer and Research Centers — Chandler

California

  • Cancer and Blood Specialty Clinic — Los Alamitos

Kansas

  • University of Kansas Medical Center Research Institute — Kansas City

Trial Details

FieldValue
Enrollment Target 351 participants
Start Date 2025-08-27
Est. Completion 2028-04-22
Phase Phase 3

Sponsor

BeOne Medicines

138 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07043400

The ClinicalTrials.gov registry entry for NCT07043400 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 351 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BeOne Medicines, which has 138 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Gastroesophageal Junction Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions — of which Cisplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07043400 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07043400 about?

NCT07043400 is a clinical study titled "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". 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 b...

What is the current status of trial NCT07043400?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 351 participants. The study started on 2025-08-27. Estimated completion is 2028-04-22.

What conditions does trial NCT07043400 study?

This clinical trial studies the following conditions: Gastroesophageal Junction Adenocarcinoma, Metastatic Gastric Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07043400?

The interventions under investigation include: Cisplatin (DRUG), Leucovorin (DRUG), Subcutaneous Tislelizumab (DRUG), Intravenous Tislelizumab (DRUG), 5-fluorouracil (5-FU) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07043400?

This trial is sponsored by BeOne Medicines, which has 138 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07043400 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial