Locally advanced esophageal cancer
Conditions
Interventions
Tracer administration: The PD-L1-targeted fluorescent tracer durvalumab-680LT
will be administered intravenously 2-4 days prior to the endoscopy at the UMCG.
Afterwards, patients will be monitored f
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 - 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 - 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 chemoradiotherapy according to the patient*s medical history; - Received a different investigational drug within 30 days prior to the dose of durvalumab-IRDye680LT according to the patient*s medical history; - History of infusion reactions to durvalumab or other monoclonal antibodies according to the patient*s medical history;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety and feasibility of quantitative fluorescence endoscopy using the fluorescent tracer durvalumab-680LT to get more insight in the heterogeneity of programmed death-1 ligand (PD-L1) expression before and after neoadjuvant therapy in patients with locally advanced EC. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To quantify optical properties and fluorescence signals in vivo and ex vivo using multi-diameter single-fiber reflectance, single-fiber fluorescence (MDSFR/SFF) spectroscopy measurements; - To compare the fluorescence intensity and tumor-to-background (TBR) of the fluorescent tracer durvalumab-680LT before and after neoadjuvant therapy; - To correlate and validate fluorescence signals detected in vivo with ex vivo histopathology, immunohistochemistry; - To compare PD-L1 expression detected during study-specific procedures with the standard biopsies to assess spatial heterogeneity; - To assess the (sub)-cellular location and distribution of durvalumab-680LT by ex vivo fluorescence microscopy; - To determine the most optimal dose of durvalumab-680LT for fluorescence molecular endoscopy if the lowest dose proves to be insufficient; - To evaluate the feasibility of molecular fluorescence endoscopy for in vivo detection of fluorescence; - To validate single fiber reflection / single fiber fluorescence (SFR/SFF) spectroscopy measurements to identify submucosal residual tumor expression, and to distinguish between positive and negative lymph nodes and to correlate to cytology results; | — |
Countries
Netherlands
Outcome results
None listed