Идёт набор NCT07472153

PD-1 (Programmed Death-1) Versus PD-L1 (Programmed Death-ligand 1) Immune Check Point Inhibitors Combined With Chemotherapy, With or Without Bevacizumab, In Patients With Metastatic, Persistent Or Recurrent Cervical Cancer

Фаза II / Фаза III С лечением Metastatic Cervical Cancer Persistent Cervical Cancer Recurrent 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: PD-1 antibody, PD-L1 antibody, Chemotherapy and bevacizumab (CT-BEV).
Кому может быть актуально: Состояния в реестре: Metastatic Cervical Cancer, Persistent Cervical Cancer, Recurrent Cervical 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 Validate, Develop and Implement The Scope of Medical Care for Metastatic, Persistent and Recurrent Cervical Cancer Using The Method of Chemoimmunotargeted Therapy

Обзор

This is a randomized trial evaluating the results of using of PD-1 and PD-L1 immune checkpoint inhibitors combined with chemotherapy, with or without bevacizumab, in patients with metastatic, persistent, and recurrent cervical cancer.

Вмешательства

Препарат PD-1 antibody
Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 + PD-1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of treatment according to the regimen of PD-1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days.
Препарат PD-L1 antibody
Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 + PD-L1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of treatment according to the regimen of PD-L1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days.
Препарат Chemotherapy and bevacizumab (CT-BEV)
Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of bevacizumab 7-10 mg/kg every 21 days.

Первичные конечные точки

Overall survival [Срок оценки: From enrollment through study completion, an average of 2 year]
Median overall survival [Срок оценки: From date of treatment initiation until the date of death from any cause, assessed up to 36 months]

Вторичные конечные точки (4)

Objective response rate [Срок оценки: From randomization until progression or study completion, average of 60 months]
Duration of response [Срок оценки: From date of first documented response until progression or death, assessed up to 60 months]
Disease-free survival [Срок оценки: From enrollment through study completion, an average of 2 year]
Median Disease-free survival [Срок оценки: From date of treatment initiation until the date of death from any cause, assessed up to 36 months]

Критерии участия

Критерии включения

Age ≥18-≤75 years.
Histologically confirmed diagnosis.
One of the forms of the cervical cancer:

Metastatic cervical cancer (stage IVB according to FIGO (International Federation of Gynaecology and Obstetrics) 2018);
Persistent cervical cancer (primary incurability after radical treatment for stages IIB-IVA cervical cancer according to FIGO 2018);
Reccurent cervical cancer (first recurrence after completed radical treatment for IA-IVB cervical cancer according to FIGO 2018).
Availability of material for determining PD-L-1 expression for immunotherapy candidates.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
No contraindications to chemotherapy, immunotherapy, or bevacizumab.
Signed informed consent to participate in the study.