PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial 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: Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA).
- Кому может быть актуально
- Состояния в реестре: Endometrial Cancer, Endometrioid Carcinoma, Mismatch Repair Deficiency. Базовые параметры: 18 лет — 45 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
- 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
PD-1 Inhibitor Combined With Progesterone Treatment in Fertility Sparing Therapy for Mismatch Repair-deficient Endometrial Cancer
Обзор
The objective of this study was to investigate the feasibility of a PD-1 inhibitor in combination with progesterone as a means of preserving fertility in patients with early-stage mismatch repair-deficient (MMRd) endometrial cancer who wish to preserve fertility.
Подробное описание
Endometrial cancer (EC) is a prevalent gynecological cancer with an escalating global incidence. The standard treatment for endometrial cancer is total hysterectomy and bilateral salpingo-oophorectomy. However, given the rising incidence of endometrial cancer in younger individuals and the the delay in the age of human reproduction, the conservation of endometrial cancer has garnered heightened attention. Clinical practice has demonstrated that high-dose progesterone can reverse the lesioned endometrium, thereby providing a rationale for the conservative treatment of early-stage endometrial cancer.
PD-1 inhibitor has been utilized as a salvage treatment in many cancers including ovarian cancer, cervical cancer, lung cancer, gastric cancer and endometrial cancer. As endometrial cancer showed MMRd rates, it is assumed to be highly responsive to PD-1 inhibitor treatment. Previous literature has reported that the efficacy of progesterone therapy is limited in patients with a MMRd status.Here we want to investigate the feasibility of PD-1 inhibitor combined with progesterone in early stage endometrial cancer patients who want to preserve fertility.
Вмешательства
- Препарат Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)
1. Sintilimab or Pembrolizumab 200mg intravenous injection, every 3 weeks 2. MA, 320mg/MPA, 500mg, po, once a day
Первичные конечные точки
- Complete remission (CR) rate [Срок оценки: From start of treatment to trial completion, an average of 3 months]
- Time to CR [Срок оценки: From start of treatment to trial completion, an average of 3 months]
Вторичные конечные точки (6)
- Recurrence rate [Срок оценки: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR]
- Pregnancy rate [Срок оценки: 1 year after CR]
- Live birth rate [Срок оценки: 1 year after pregnancy]
- Pathological biomarker [Срок оценки: From the start of treatment to CR，including 3 months, 6 months, 9 months, and so forth.]
- CA125 [Срок оценки: From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.]
- Adverse reactions [Срок оценки: From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.]
Критерии участия
Критерии включения
- Be between the ages of 18-45 years old;
- Stage IA (FIGO 2009) ;
- Confirmed diagnosis of endometrial adenocarcinoma G1-G2 based upon D\&C or hysteroscopy;
- Molecular classification of MMRd, determined by immunohistochemical (IHC) for MMR proteins and by the second generation sequencing (NGS) or microsatellite polymerase chain reaction (PCR);
- With a strong desire for fertility preservation;
- Sign the informed consent.
Критерии исключения
- Stage IB(FIGO 2009) and above；
- Tumour differentiation of G3 or non-endometrioid adenocarcinoma；
- Complicated with any other malignancy；
- Contraindicated to conservative treatment or the use of pharmaceuticals.
- Contraindications to pregnancy, or judged by the researcher to be unfit for pregnancy or delivery.
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
- Peking University People's Hospital — Пекин
Идентификаторы
NCT: NCT06549855 · 2024MMRdECFerSp