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Набор скоро начнётся NCT06977594

Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer

Без фазы С лечением Ovarian Cancer Endometrial Cancer Cervical 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: Proactive immune tolerance induction, Standard Treatment, Paclitaxel and carboplatin, Standard premedication (20 mg).
Кому может быть актуально
Состояния в реестре: Ovarian Cancer, Endometrial Cancer, Cervical Cancer. Базовые параметры: от 19 лет · Женщины.
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

A Randomized, Placebo-controlled, Parallel-group, Open-label Trial to Evaluate the Efficacy of Proactive Immune Tolerance Induction to Paclitaxel and Carboplatin in Patients With Gynecologic Cancer

Обзор

The goal of this clinical trial is to evaluate the efficacy of proactive immune tolerance induction of chemotherapy (paclitaxel and carboplatin) for patients with gynecologic cancer. The main questions it aims to answer are: \- Does immune tolerance induction during the first three cycles of chemotherapy reduce the incidence of hypersensitivity reactions in the remaining cycles? Participants will: * Undergo immune tolerance induction or standard treatment during the first three cycles of chemotherapy as randomized, after which all participants will continue the remaining cycles with standard treatment. * Receive a reduced dose of dexamethasone premedication if assigned to the experimental group, depending on the specific protocol of each clinical trial.

Подробное описание

Proactive immune tolerance induction is applied using an automated infusion pump with a pre-programmed protocol. It follows the same stepwise dosing scheme as conventional desensitization therapy used in patients who have experienced hypersensitivity reactions before. However, it is uniquely performed in patients without a prior history of hypersensitivity reactions, aiming to prevent sensitization itself.

Вмешательства

  • Другое Proactive immune tolerance induction
    Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles
  • Другое Standard Treatment
    Standard treatment throughout all chemotherapy cycles
  • Препарат Paclitaxel and carboplatin
    A chemotherapy regimen for gynecologic cancers.
  • Препарат Standard premedication (20 mg)
    Premedication includes 20 mg of dexamethasone.
  • Препарат Reduced premedication (10 mg)
    Premedication includes 20 mg of dexamethasone.
  • Препарат Reduced premedication (5 mg)
    Premedication includes 5 mg of dexamethasone.

Первичные конечные точки

  • Hypersensitivity reaction incidence [Срок оценки: From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions).]
Вторичные конечные точки (6)
  • Chemotherapy completion rate [Срок оценки: From chemotherapy initiation to the last cycle in each patient, an average of 6 months]
  • Severity of hypersensitivity reaction [Срок оценки: From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions).]
  • Patients' quality of life [Срок оценки: From chemotherapy initiation to the last cycle, an average of 6 months]
  • Tumor Response Rate [Срок оценки: At every third chemotherapy cycle in each patient]
  • Survival rate [Срок оценки: At study completion in each patient, an average of 1 year]
  • Recurrence Rate [Срок оценки: At study completion in each patient, an average of 1 year]

Критерии участия

Критерии включения

  • Patients receiving paclitaxel and carboplatin chemotherapy for gynecologic malignancies.
  • Patients with no prior history of hypersensitivity reactions to paclitaxel or carboplatin.
  • Patients who are able to read and voluntarily provide written informed consent.
  • Aged 19 years or older.

Критерии исключения

  • Patients who do not wish to participate in this study voluntarily.
  • Patients who, in the opinion of the investigator, are unsuitable for participation in this clinical trial.

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
Профилактика

Центры проведения

South Korea · 1 центр
  • Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT06977594 · PINTO_C

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗