Esophageal cancer esophageal cancer
Conditions
Interventions
Tracer administration: The PD-L1-targeted fluorescent tracer durvalumab-680LT and PD-1targeted fluorescent tracer nivolumab-800CW will be administered intravenously 2 – 4 daysprior to the endoscopy at
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of our newly built dual-wavelength spectroscopy system in combination withthe fluorescent tracers durvalumab-680LT and nivolumab-800CW to gain insight in theheterogeneity of the PD-1/PD-L1 expression before and after neoadjuvant therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the safety of dual tracer administration of nivolumab-800CW anddurvalumab-680LT by evaluating vital parameters, AE's, SAE's and SUSARS.- To compare the fluorescence intensity of the fluorescent tracer durvalumab-680LT andnivolumab-800CW before and after neoadjuvant therapy;- To investigate the correlation between fluorescence signals detected in vivo with exvivo histopathology, immunohistochemistry;- To compare PD-L1 and PD-1 expression detected during study-specific procedureswith the standard biopsies to assess spatial heterogeneity;- To assess the (sub)-cellular location and distribution of durvalumab-680LT andnivolumab-800CW by ex vivo fluorescence microscopy;- To determine the most optimal dose of nivolumab-800CW for fluorescence molecularendoscopy. | — |
Countries
Netherlands
Contacts
Public ContactYJ Ginkel
Universitair Medisch Centrum Groningen
Outcome results
None listed