Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer

Официальное название

Irinotecan Hydrochloride Liposome Injection (II) in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Nab-paclitaxel in Combination With Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.

Обзор

This study is a randomized, open-label, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Irinotecan Hydrochloride Liposome Injection (II) combined with oxaliplatin and 5-FU/LV versus nab-paclitaxel combined with gemcitabine as first-line treatment for advanced pancreatic cancer.

Вмешательства

• Препарат Irinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinate
  Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate
• Препарат nab-paclitaxel; gemcitabine
  nab-paclitaxel in combination with gemcitabine

Первичные конечные точки

• Overall survival (OS) [Срок оценки: From study start until target OS events have occurred (approximately 18 months after last patient enrollment)]

Вторичные конечные точки (4)

• Objective Response rate (ORR) [Срок оценки: up to 6 months following the date the last patient was randomized]
• Disease Control Rate [Срок оценки: up to 6 months following the date the last patient was randomized]
• Duration of Response [Срок оценки: up to 6 months following the date the last patient was randomized]
• Progression free survival (PFS) [Срок оценки: From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first,assessed up to 18 months]

Критерии участия

Критерии включения

• ECOG performance status 0 or 1
• Histological or cytologically confirmed pancreatic cancer that has not been previously treated in the metastatic disease.
• Life expectancy of greater than or equal to3 months.
• At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)
• Able and willing to provide a written informed consent

Критерии исключения

• Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
• Known history of central nervous system (CNS) metastases.
• Severe infection (> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment;
• Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT07238283 · HR070803-308

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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