Идёт набор NCT07472140

PARP (Poly (ADP-ribose) Polymerase) Inhibitor With or Without Angiogenesis Inhibitor in Homologous Recombination Deficient Primary Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer

Фаза II / Фаза III С лечением Ovarian Cancer Fallopian Tube Cancers Primary Peritoneal 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: PARP inhibitor + Bevacizumab, PARP inhibitor.
Кому может быть актуально: Состояния в реестре: Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer. Базовые параметры: 18 лет — 75 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: Беларусь
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

To Develop and Implement The Scope of Medical Care for Homologous Recombination Deficient Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer of the III-IV Stages Using Maintenance Therapy With PARP Inhibitor Combined With Angiogenesis Inhibitor.

Обзор

This is a randomized trial evaluating the results of using of PARP inhibitor combined with angiogenesis inhibitor. in patients with homologous recombination deficient primary ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer of the III-IV stages.

Вмешательства

Препарат PARP inhibitor + Bevacizumab
Patients will receive 6 courses of chemotherapy according to the regimen of platinum drug + paclitaxel + bevacizumab (≥3 cycles) every 21 days. In case of a complete or partial response maintenance therapy is carried out until disease progression or intolerable toxicity or for 2 years to the regimen of PARP inhibitor + bevacizumab.
Препарат PARP inhibitor
Patients will receive 6 courses of chemotherapy according to the regimen of platinum drug + paclitaxel every 21 days. In case of a complete or partial response maintenance therapy of PARP inhibitor is carried out until disease progression or intolerable toxicity or for 2 years.

Первичные конечные точки

Disease-free survival [Срок оценки: From enrollment through study completion, an average of 2 year]
The frequency of adverse events [Срок оценки: From date of first immunotherapy dose through 60 months, or date of last patient contact]

Вторичные конечные точки (3)

Disease-free survival 2 [Срок оценки: From the first recurrence through study completion, an average of 2 year]
Time from Randomization to First Subsequent Therapy [Срок оценки: From enrollment through study completion, an average of 2 year]
The quality of life [Срок оценки: Through study completion, an average of 5 year]

Критерии участия

Критерии включения

Age ≥18-≤75 years.
Histologically confirmed diagnosis of serous or endometrioid high-grade ovarian cancer, fallopian-tube cancer or primary peritoneal cancer.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Possibility of performing diagnostic laparoscopy or cytoreductive surgery.
Presence of homologous recombination deficiency (HRD).
No contraindications to chemotherapy, or bevacizumab.
Signed informed consent to participate in the study.