Меню
Набор скоро начнётся NCT07026123

A Real-world Study of Liposomal Irinotecan (Onivyde)-Based Therapy in Patients With Locally Advanced/Metastatic Pancreatic Cancer in China

— Наблюдательное Advanced 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
В протоколе указаны: Nal-IRI (Onivyde®)-based treatment, Other second-line treatment.
Кому может быть актуально
Состояния в реестре: Advanced 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

This study is designed to evaluate the real world efficacy and safety of the liposomal irinotecan (Onivyde®)-based treatment scheme in Chinese patients with locally advanced or metastatic pancreatic cancer, and to compare the efficacy with that of the whole pancreatic cancer population who did not receive relevant treatment.

Подробное описание

Chinese patients with pancreatic cancer are mostly treated according to foreign clinical research, lacking the diagnosis and treatment data of efficacy and safety of Chinese population. In the NAPOLI-1 study, irinotecan liposomes (Onivyde®) The combination of 5-fluorouracil and folinic acid (Nal-IRI+5-FU/LV) has shown survival benefits in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have previously received gemcitabine-based treatment. The NAPOLI-3 study showed that NALIRIFOX (Nal-IRI+oxaliplatin+5-FU/LV) significantly improved overall survival (OS) and progression free survival (PFS) compared to albumin bound paclitaxel and gemcitabine in newly diagnosed mPDAC patients. However, the efficacy and safety data of Nal-IRI-based treatment regimens in China are limited. In August 2023, Onivyde® was commercially listed in China. The purpose of this study is to: ① evaluate the real world efficacy and safety of Onivyde®-based treatment schemes in Chinese patients with locally advanced or metastatic pancreatic cancer; ② analyze the efficacy of Onivyde® treatment and the efficacy of all pancreatic cancer patients who have not received relevant treatment using the project data of China Advanced pancreatic cancer Big Data Center (Renji Hospital Cancer Department is the national leading unit), in conjunction with the survival follow-up data of China Center for Disease Control and Prevention of Chronic Non communicable Diseases.

Вмешательства

  • Препарат Nal-IRI (Onivyde®)-based treatment
    Nal-IRI (Onivyde®) combined with 5-FU/LV is used for metastatic pancreatic ductal adenocarcinoma patients who have progressed after treatment with gemcitabine. The recommended dose of Nal-IRI (Onivyde®) is 70 mg/m\^2, administered intravenously for 90 minutes, once every 2 weeks. In patients known to be homozygous for the UGT1A1 \* 28 allele, the recommended starting dose of Nal-IRI (Onivyde®) is 50 mg/m\^2, administered intravenously within 90 minutes. Based on tolerance, increase the dose of N
  • Препарат Other second-line treatment
    Other second-line treatment

Первичные конечные точки

  • Overall Survival (OS) [Срок оценки: Up to 24 months]
Вторичные конечные точки (5)
  • Progression-Free Survival (PFS) [Срок оценки: Up to 24 months]
  • Time To Progress (TTP) [Срок оценки: Up to 24 months]
  • Overall Response Rate (ORR) [Срок оценки: Up to 24 months]
  • Disease Control Rate (DCR) [Срок оценки: Up to 24 months]
  • Safety and tolerability by incidence, severity and outcome of adverse events [Срок оценки: Until 30 day safety follow-up visit]

Критерии участия

Inclusion Criteria of the experimental group:

  • Age ≥ 18 years old.
  • Patients with locally advanced or metastatic PDAC diagnosed by pathology.
  • Patients who received at least one cycle of Nal-IRI (Onivyde®）+ 5-FU/LV treatment.
  • Patients who have progressed in treatment with gemcitabine or gemcitabine containing regimens in the past.
  • The patient voluntarily participates in the study and signs an informed consent form.

Inclusion Criteria of the control group:

  • Age ≥ 18 years old.
  • Patients with locally advanced or metastatic PDAC diagnosed by pathology.
  • Not received Nal IRI (Onivyde®)+ 5-FU/LV treatment in the past.

Критерии исключения

  • Confirm pregnant or lactating women.
  • The patient's clinical data is not available.
  • The researchers determined that they were not suitable for inclusion in the study due to other circumstances.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Шанхай

Идентификаторы

NCT: NCT07026123 · IIT-95013-002-CHN

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗