A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma
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: Intensity-modulated radiotherapy (IMRT), Tislelizumab, Cisplatin, Nab paclitaxel.
- Кому может быть актуально
- Состояния в реестре: Esophageal Squamous Cell Carcinoma. Базовые параметры: от 18 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
Chemoradiation Versus Chemotherapy in Combination with Tislelizumab As First Line Treatment for Advanced Esophageal Squamous Cell Carcinoma with Low PD-L1 Expression (RENMIN-236): Multicentre, Randomised, Phase 3 Trial
Обзор
This study is a multicentre, randomised, parallel-controlled, open-label, 3 phase clinical trial. The subjects were untreated, unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma with low PD-L1 expression. Patients were randomly assigned to receive chemoradiation or chemotherapy in combination with Tislelizumab at a ratio of 1: 1. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We hypothesized that in advanced esophageal squamous cell carcinoma patients with low PD-L1 expression, chemoradiation versus chemotherapy in combination with Tislelizumab will significantly improve PFS.
Вмешательства
- Лучевая терапия Intensity-modulated radiotherapy (IMRT)
Esophageal primary tumor: 39.6Gy/2.2Gy Bone metastasis: 30Gy/3Gy Lung, liver, brain metastases, metastatic lymph nodes: 45Gy/3Gy - Препарат Tislelizumab
200 mg IV Q3W - Препарат Cisplatin
During concurrent radiation therapy: 25 mg/m² IV QW During consolidation therapy: 75 mg/m² IV Q3W - Препарат Nab paclitaxel
During concurrent radiation therapy: 75 mg/m² IV QW During consolidation therapy: 220 mg/m² IV Q3W
Первичные конечные точки
- Progression-Free Survival (PFS) [Срок оценки: Approximately 40 months from date of the first participant randomization]
Вторичные конечные точки (4)
- Overall Survival (OS) [Срок оценки: Approximately 40 months from date of the first participant randomization]
- Objective Response Rate (ORR) [Срок оценки: Approximately 40 months from date of the first participant randomization]
- Duration of Response (DOR) [Срок оценки: Approximately 40 months from date of the first participant randomization]
- Number of participants experiencing Adverse Events (AEs) [Срок оценки: Approximately 40 months from date of the first participant randomization]
Критерии участия
Критерии включения
- Subjects must have histologically confirmed squamous cell carcinoma of esophagus (per AJCC 8th edition).
- Subjects must have unresectable advanced, recurrent or metastatic ESCC.
- Subjects must not be amenable to curative approaches such as definitive chemoradiation and/or surgery.
- PD-L1 expression (CPS) is less than 10.
- No prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease.
- ECOG Performance Status of 0 or 1.
- Subjects must have at least one measurable lesion by CT or MRI per RECIST 1.1 criteria; radiographic tumor assessment must be performed within 28 days prior to randomization.
- Subjects must have adequate organ and bone marrow function.
Критерии исключения
- Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment.
- Active known or suspected autoimmune disease.
- Any serious or uncontrolled medical disorder or active infection.
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus.
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
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
- Лечение
Центры проведения
Китай · 1 центр
- Renmin hosptial of Wuhan University — Ухань
Идентификаторы
NCT: NCT05919030 · WDRY2023-K088