esophageal cancer locally advanced esophageal cancer
Conditions
Interventions
Patients will undergo optimally two fluorescence endoscopies: before and after
nCRT.
The patients involved will receive an intravenous administration of
bevacizumab-800CW at the dosage of 4.5mg thre
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Locally advanced esophageal carcinoma (cT1b-4a N0-3 M0) in multi-disciplinary esophageal oncology meeting agreed on long course neoadjuvant chemoradiotherapy, followed by esophagectomy; - Age >= 18 years; - Written informed consent.
Exclusion criteria
Exclusion criteria: - Patients with psychological diseases or medical issues who are not able to sign informed consent form; • Concurrent uncontrolled medical conditions; • 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 primary tumor prior to start of neoadjuvant chemoradiotherapy • Received a different investigational drug within 30 days prior to the dose of bevacizumab-800CW; • History of infusion reactions to bevacizumab or other monoclonal antibodies;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of this study include • Discrimination of tumorous and non-tumorous tissue based on in vivo and ex vivo fluorescence measurements from bevacizumab-800CW gained during fluorescence endoscopy procedures; • The safety of bevacizumab-800CW through monitoring vital signs, the injection site and evaluating possible (severe) adverse events (SAE/AEs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints • The correlation of in vivo and ex vivo fluorescent signals to histopathological analysis results. • Quantification of fluorescent signal by MDSFR/SFF spectroscopy; • The localization and distribution of bevacizumab-800CW fluorescent signal at cell level observed in-vivo by CLE; • Assessment of the (sub-)cellular distribution of bevacizumab-800CW by ex-vivo fluorescence microscopy. • The variation in fluorescence intensity between FME before and after nCRT. • The correlation of in vivo and ex vivo OFDI measurements to histopathological analysis results. • Differentiate between positive and negative lymphnodes based on SFR/SFF spectroscopy measurements • The correlation of in vivo measurements to cytology results. • Safety evaluation of (serious) adverse events and suspected unexpected serious adverse events related to SFR/SFF • The most optimal dose of bevacizumab-800CW for fluorescence molecular endoscopy. Other study parameters • Patient characteristics (age, sex, history, morbidity, nCRT completed, treatment outcome, prognosis, basic vital signs before and after tracer administration). • surgical specimen characteristics (according to standard reports from pathologists). | — |
Countries
Netherlands
Outcome results
None listed