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Идёт набор NCT06902545

A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.

— Наблюдательное Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer Metastatic Gastric Adenocarcinoma or Cancer Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: zolbetuximab.
Кому может быть актуально
Состояния в реестре: Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Post-marketing Observational Study of VYLOY (Zolbetuximab) Injection 100 mg, 300 mg for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in South Korea

Обзор

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).

Вмешательства

  • Препарат zolbetuximab
    Intravenous

Первичные конечные точки

  • Number of patients with an adverse event (AE) [Срок оценки: Up to 54 Weeks after the first administration of VYLOY]
  • Number of patients with an adverse drug reaction (ADR) [Срок оценки: Up to 54 Weeks after the first administration of VYLOY]
  • Number of patients with a serious AE (SAE) [Срок оценки: Up to 54 Weeks after the first administration of VYLOY]
  • Number of patients with a serious ADR (SADR) [Срок оценки: Up to 54 Weeks after the first administration of VYLOY]
  • Number of patients with an unexpected AE (UAE) [Срок оценки: Up to 54 Weeks after the first administration of VYLOY]
  • Number of patients with an unexpected ADR (UADR) [Срок оценки: Up to 54 Weeks after the first administration of VYLOY]
  • Number of patients who died during the study [Срок оценки: Up to 54 Weeks after the first administration of VYLOY]
  • Number patients with an AE leading to death [Срок оценки: Up to 54 Weeks after the first administration of VYLOY]
  • Number of patients with an important risk compared to number of patients evaluated [Срок оценки: Up to 54 Weeks after the first administration of VYLOY]
Вторичные конечные точки (1)
  • Progression free survival (PFS) [Срок оценки: Up to 54 Weeks after the first administration of VYLOY]

Критерии участия

Критерии включения

  • Patients who receive treatment with VYLOY injection, according to the approved local label.

Критерии исключения

  • Patients with any contraindication for VYLOY injection, according to the approved local label.
  • Patients who are registered or scheduled to be registered in any clinical trials involving investigational drug administration.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 13 центров
  • KR82010 — Goyang-si
  • KR82008 — Suwon
  • KR82009 — Suwon
  • KR82006 — Yangsan
  • KR82012 — Hwasun Gun
  • KR82001 — Seoul
  • KR82002 — Seoul
  • KR82003 — Seoul
  • … и ещё 5 центров

Идентификаторы

NCT: NCT06902545 · 8951-PV-0001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗