An observational study in Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer and Metastatic Gastric Adenocarcinoma or Cancer, sponsored by Astellas Pharma Korea, Inc.. Recruiting at 15 sites in South Korea. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Astellas Pharma Korea, Inc. (part of Astellas Pharma Inc) · Observational
This study is for people in South Korea who have cancer in or around the stomach (gastric cancer) or cancer where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Their cancer is locally advanced, unresectable, or metastatic. Locally advanced means the cancer has spread to tissue close by. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body.
In South Korea, VYLOY is approved for the treatment of gastric cancer or GEJ cancer. The people in this study will receive VYLOY as part of their usual treatment for their cancer. In standard clinical practice VYLOY is given to people slowly through a tube into a vein.
The main aim of the study is to collect information in a real-world setting about the safety of VYLOY in people with gastric cancer or GEJ cancer in clinics in South Korea. This study will also help researchers learn how long people's gastric cancer or GEJ cancer stays stable.
This study is about collecting information only. This is known as an observational study. The individual's doctor decides on treatment, not the sponsor (Astellas). The study will last about 1 year (54 weeks).
620 studies on the registry are indexed under Adenocarcinoma; 148 are open to participants now.
This study's planned enrollment of 377 is above the median of 182 across 98 observational studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Astellas Pharma Korea, Inc. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who have locally advanced unresectable or metastatic HER2-negative, and CLDN18.2-positive, gastric or GEJ adenocarcinoma who are prescribed VYLOY injection in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first line treatment in South Korea.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who receive treatment with Vyloy injection 100 mg or 300 mg (zolbetuximab), according to the approved local label.
Drug: zolbetuximab
Intravenous
Also known as: Vyloy
Number of patients with an adverse event (AE)
Adverse events (AEs) will be coded using MedDRA. An AE is defined as any untoward medical occurrence in a patient administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Time frame: Up to 54 Weeks after the first administration of VYLOY
Number of patients with an adverse drug reaction (ADR)
An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship is at least a reasonable possibility.
Time frame: Up to 54 Weeks after the first administration of VYLOY
Number of patients with a serious AE (SAE)
An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, requires hospitalization or prolongation to hospitalization results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect, or other medically important event.
Time frame: Up to 54 Weeks after the first administration of VYLOY
Number of patients with a serious ADR (SADR)
An ADR considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, requires hospitalization or prolongation to hospitalization results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect, or other medically important event.
Time frame: Up to 54 Weeks after the first administration of VYLOY
Number of patients with an unexpected AE (UAE)
An UAE is an AE that the nature or severity of which is not consistent with the information in the Precautions in Use Section of approved Korean label.
Time frame: Up to 54 Weeks after the first administration of VYLOY
Number of patients with an unexpected ADR (UADR)
An UADR is defined as an unexpected adverse drug reaction.
Time frame: Up to 54 Weeks after the first administration of VYLOY
Number of patients who died during the study
Time frame: Up to 54 Weeks after the first administration of VYLOY
Number patients with an AE leading to death
Time frame: Up to 54 Weeks after the first administration of VYLOY
Number of patients with an important risk compared to number of patients evaluated
An important risk is classified as an important identified risk and an important potential risk. An identified risk is defined as the risk that correspond to undesirable clinical outcomes, with sufficient scientific evidence that the undesirable clinical outcome is caused by the drug. "Important Identified Risks" are identified risks that have the potential to affect the risk-benefit balance of a product. An potential risk is defined as the risk that correspond to undesirable clinical outcomes, with some, but not sufficient, evidence to estimate that the undesirable clinical outcome is caused by the drug. "Important Potential Risks" are potential risks that have the potential to affect the risk-benefit balance of a product.
Time frame: Up to 54 Weeks after the first administration of VYLOY
Progression free survival (PFS)
PFS is defined as time from start of VYLOY to progressive disease (PD) or death from any cause, whichever occurs first.
Time frame: Up to 54 Weeks after the first administration of VYLOY
Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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