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Набор скоро начнётся NCT06688240

A Multi-center, Single-arm, Prospective Non-interventional Study to Investigate the Safety Profiles and Effectiveness of Liposomal Irinotecan (ONIVYDE®) in Combination with 5-fluorouracil (5-FU) and Leucovorin (LV) in Chinese Patients with Metastatic Pancreatic Cancer As Approval Condition (SEOPAC)

— Наблюдательное Metastatic Pancreatic Cancer

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Metastatic Pancreatic Cancer. Базовые параметры: от 18 лет · 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The aim of this phase 4 study is to evaluate the safety profile of ONIVYDE in China mainland. Primary objective To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects: 1. Quantify the rate of grade ≥3 neutropenia (primary objective) 2. Serious adverse events and serious adverse drug reactions 3. Adverse events and adverse drug reactions Secondary objective To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland. (1) Overall survival (2) Overall response (3) Progression free survival (4) Quality of life assessment

Первичные конечные точки

  • To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects: [Срок оценки: From enrolment until 30 days after last ONIVYDE administration]
  • To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects: [Срок оценки: From enrolment until 30 days after last ONIVYDE administration]
  • To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects: [Срок оценки: From enrolment until 30 days after last ONIVYDE administration]
Вторичные конечные точки (4)
  • To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland. [Срок оценки: From FPI to 12 months after LPI]
  • To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland. [Срок оценки: From FPI to 12 months after LPI]
  • To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland. [Срок оценки: From FPI to 12 months after LPI]
  • To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland. [Срок оценки: From FPI to 12 months after LPI]

Критерии участия

Критерии включения

  • The adult patient (≥18 years of age) has given written informed consent to participate in the study.
  • The patient has been prescribed for ONIVYDE treatment according to the ONIVYDE China mainland SmPC.
  • Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas.
  • Documented metastatic disease.
  • Patient deemed not eligible or failed previous treatment with gemcitabine or gemcitabine containing therapy.

Критерии исключения

  • Patients who have experienced a severe hypersensitivity reaction to ONIVYDE or Irinotecan HCL.
  • Patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation or confirmed diagnostic of interstitial lung disease.
  • Pregnant or nursing (lactating) women.
  • Patients without highly effective methods of contraception during study treatment until 3 months after the last dose of the study drug, Specially,7 months for women of childbearing potential and 4 months for male with partners of childbearing potential after the last dose of the study drug.
  • Other additional exclusions may be applied by the investigator according to the contexts, in order to ensure that the study population will be non-interventional but representative of all eligible subjects.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06688240 · SAF-95013-001-CHN

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗