Optical PD-1 and PD-L1 Imaging in Locally Advanced Esophageal Cancer Using Durvalumab-680LT and Nivolumab-800CW

Официальное название

Optical PD-1 and PD-L1 Imaging Using Dual-wavelength Quantitative Fluorescence Endoscopy in Locally Advanced Esophageal Cancer Using Durvalumab-680LT and Nivolumab-800CW

Обзор

Radiation and chemotherapy can shrink the tumor. For certain types of cancer, immunotherapy is added to further reduce the tumor size. Immunotherapy works for some patients and can sometimes keep the cancer under control for a long time. Unfortunately, immunotherapy does not work for every patient. That's why researchers around the world are looking for new ways to predict who will benefit from immunotherapy and who will not. It is likely that immunotherapy is more effective when the tumor or immune cells have specific targets, such as the proteins PD-L1 or PD-1. Unfortunately, clinicians cannot reliably detect these proteins through blood tests or tissue samples, because their presence can vary throughout the tumor. With this study, the investigators hope to use a new technique called 'fluorescence endoscopy' during an endoscopic ultrasound of the esophagus to visualize whether the PD-L1 or PD-1 proteins are present in esophageal cancer or immune cells. Additionally, the investigators aim to investigate whether the presence of these proteins changes before and after chemotherapy and/or radiation. This will help us determine the best timing for measuring these proteins in the future. What is fluorescence endoscopy? To determine whether the proteins are present, participants in this study will receive two 'tracers' via an IV beforehand. The first tracer is a fluorescent substance-a kind of 'glow-in-the-dark' compound-attached to a drug that binds to PD-L1 proteins in esophageal cancer. The second fluorescent tracer binds to PD-1 proteins on immune cells. During fluorescence endoscopy, the investigators use special equipment to detect these tracers in the esophagus. This information may help us better identify which patients are suitable for immunotherapy treatment and which are not.

Вмешательства

• Устройство Spectroscopy system
  System that measures the fluorescence intensity in tissue in vivo.
• Препарат Nivolumab-800CW
  Fluorescent tracer
• Препарат Durvalumab-680LT
  Fluorescent tracer

Первичные конечные точки

• Feasiblity [Срок оценки: Up to 14 months]
• Safety of dual tracer administratio [Срок оценки: Up to 14 months]

Вторичные конечные точки (9)

• Safety of dual tracer administration [Срок оценки: Up to 14 months]
• Safety of dual tracer administration [Срок оценки: Up to 14 months]
• Safety of dual tracer administration [Срок оценки: Up to 14 months]
• Safety of dual tracer administration [Срок оценки: Up to 14 months]
• Correlation between in vivo signal and ex vivo pathology [Срок оценки: Up to 14 months]
• Correlation of fluorescence intensity before and after neoadjuvant therapy [Срок оценки: Up to 14 months]
• Correlation between in vivo signal and ex vivo analysis [Срок оценки: Up to 14 months]
• Investigate the sub-cellular location of the drugs. [Срок оценки: Up to 14 months]
• Optimal dose determination of nivolumab-800CW [Срок оценки: up to 12 months]

Критерии участия

Критерии включения

• Lesion suspected for locally advanced EC (cT1b-4a N0-3 M0);
• Indication for neoadjuvant therapy or definitive chemo-radiation therapy;
• Age ≥ 18 years;
• Written informed consent.

Критерии исключения

• Medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician;
• Concurrent uncontrolled medical conditions according to treating medical physician;
• Medical history of auto-immune disease and on active treatment;
• Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause);
• Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of the primary tumor prior to start of neoadjuvant therapy according to the patient's medical history;
• Received an investigational drug within 30 days prior to the tracer administration according to the patient's medical history;
• History of infusion reactions to durvalumab or nivolumab or other monoclonal antibodies according to the patient's medical history;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07196384 · UMCG 21164 · 2024-520090-12-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗