Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck 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: Immunotherapy.
- Кому может быть актуально
- Состояния в реестре: Head and Neck Cancer. 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
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This project aims to organise the sampling of blood and tumor at key points of the standard of care of patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (HNSCC). This will allow to identify new potential predictive biomarkers of efficacy of immunotherapy and to investigate the evolution of the tumoral microenvironment after successive systemic treatments.
Подробное описание
Tumor and blood samples will be collected on patients treated by anti-PD1 immunotherapy at different timepoints. Tumor samples will be collected (i) before initiation of immunotherapy, (ii) at 50 days after initiation of immunotherapy and, optionally, in case of disease progression, (iii) before the initiation of the new line of chemotherapy and (iv) at 50 days after initiation of chemotherapy. Blood samples will be collected : (i) before initiation of immunotherapy, (ii) at each cycles of treatment until 84 days after initiation of immunotherapy and, optionally, in case of disease progression, (iii) before the initiation of the new line of chemotherapy and (iv) at each cycle until 50 days after initiation of chemotherapy (maximum 2 samples per month).
Вмешательства
- Препарат Immunotherapy
anti-PD1
Первичные конечные точки
- prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response. [Срок оценки: at 3 months after initiation of immunotherapy]
- prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response. [Срок оценки: at 3 months after initiation of immunotherapy]
Вторичные конечные точки (7)
- Prospective validation of the expression of interferon-gamma signature to predict progression free survival. [Срок оценки: at 3 years after inclusion]
- Prospective validation of the expression of interferon-gamma signature to predict overall survival. [Срок оценки: at 3 years after inclusion]
- Prospective validation of the expression of interferon-gamma signature to predict duration of objective response. [Срок оценки: at 3 years after inclusion]
- Exploratory outcome : investigation of the expression of other molecular signatures such as immune cells panel within the tumor microenvironment to predict anti-PD1 immunotherapy response. [Срок оценки: at 3 months after initiation of immunotherapy]
- Exploratory outcome : investigation of the expression of other molecular signatures such as immune checkpoints protein expression level to predict anti-PD1 immunotherapy response. [Срок оценки: at 3 months after initiation of immunotherapy]
- Exploratory outcome : investigation of the expression of other molecular signatures such as biomarkers expression level involved in immunogenic cell death and in mitophagy to predict anti-PD1 immunotherapy response. [Срок оценки: at 3 months after initiation of immunotherapy]
- Exploratory outcome : investigation of the expression of other molecular signatures such as protein expression level involved in hypoxia to predict anti-PD1 immunotherapy response. [Срок оценки: at 3 months after initiation of immunotherapy]
Критерии участия
Критерии включения
- Patients with recurrent squamous-cell carcinoma of the head and neck not amenable to local therapy and/or with metastatic disease
- Tumor directly accessible to clinical examination (tumor of oral cavity and of oropharynx) and/or cervical lymphadenopathy accessible to echography allowing to realise biopsy under local anesthesia
- Indication to treatment by anti-PD1 immunotherapy according to French competent authority recommendations
- Performance status 0, 1 or 2
- At least one measurable lesion on RECIST V1.1 criteria
Критерии исключения
- Head and neck squamous cell carcinoma accessible to a local treatment
- Cancer of nasopharynx, sinus or nasal cavity
- Other histology than epidermoid
- Patients with contraindication for anti-PD1 immunotherapy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Франция · 1 центр
- Institut de cancérologie Strasbourg Europe — Strasbourg
Публикации
- Helene C, Conrad O, Pflumio C, Borel C, Voegelin M, Bernard A, Schultz P, Onea MA, Jung A, Martin S, Burgy M. Dynamic profiling of immune microenvironment during anti-PD-1 immunotherapy for head and neck squamous cell carcinoma: the IPRICE study. BMC Cancer. 2023 Dec 8;23(1):1209. doi: 10.1186/s12885-023-11672-x. PMID 38066522
Идентификаторы
NCT: NCT05328024 · 2021-003