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Идёт набор NCT06151262

A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer

Фаза II С лечением 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: Trilaciclib+mFOLFIRINOX.
Кому может быть актуально
Состояния в реестре: Pancreatic Cancer. Базовые параметры: 18 лет — 75 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 →

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Официальное название

A Single-arm, Exploratory Clinical Study of Trilaciclib Combined With mFOLFIRINOX Regimen in the Treatment of Patients With Advanced Pancreatic Cancer

Обзор

To observe the incidence of chemotherapy-induced myelosuppression and the safety of Trilaciclib combined with mFOLFIRINOX in patients with advanced pancreatic cancer receiving first-line treatment.

Подробное описание

This study was a single-arm, exploratory clinical study. Patients with advanced pancreatic cancer were screened and enrolled according to the inclusion and exclusion criteria described in the study protocol. Informed consent was signed after full communication. Patients with advanced pancreatic cancer who received first-line treatment were treated with Trilaciclib +mFOLFIRINOX. The incidence of chemotherapy-induced myelosuppression was used as the primary endpoint to observe whether Trilaciclib could reduce the occurrence or degree of chemotherapy-induced myelosuppression.

Вмешательства

  • Препарат Trilaciclib+mFOLFIRINOX
    This was a single-arm, exploratory study of the combination of Trilaciclib and mFOLFIRINOX in patients with advanced pancreatic cancer receiving first-line therapy. Observed the incidence of chemotherapy-induced myelosuppression, and imaging was performed every four cycles to assess tumor response.

Первичные конечные точки

  • Incidence of CIM [Срок оценки: During treatment. Treatment cycles of 14 days continued from the first dose until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (up to 24 months）]
Вторичные конечные точки (3)
  • OS [Срок оценки: From date of randomization until the date of death(up to 24 months)]
  • PFS [Срок оценки: From date of first dose of study drug to radiographic disease progression（Up to 24 months）]
  • Safety and Tolerability [Срок оценки: Up to 36 months]

Критерии участия

Критерии включения

  • Age 18-75 years
  • ECOG score 0 or 1
  • Expected survival≥12 weeks
  • Patients with histologically or cytologically confirmed pancreatic cancer
  • Have not received any antineoplastic therapy prior to treatment
  • Major organ functions within 7 days prior to treatment shall meet the following criteria: a. Neutrophil count ≥1.5×109 /L； b. Hemoglobin ≥10g/dL； c. Platelet count ≥100×109 /L
  • Biochemical examination shall meet the following standards: a、Total bilirubin(TBIL)≤1.5times the upper limit of normal value(ULN); b、ALT and AST≤1.5×ULN ; c、creatinine clearance(CCr)≥60ml/min
  • Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures
  • Subjects voluntarily joined the study and signed an informed consent form(ICF)
  • It is expected that the patient has good compliance and can follow up the efficacy and adverse reactions according to the protocol requirements

Критерии исключения

  • Had received systemic antineoplastic therapy
  • Pregnant and lactating women. Women of childbearing age had to test a negative pregnancy test within 7 days before enrollment
  • Substance abuse, clinical or psychological or social factors that may interfere with informed consent or the conduct of the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The Affiliated Hospital of Nanjing University Medical School — Нанкин

Идентификаторы

NCT: NCT06151262 · 2023-419-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗