Optical PD-L1 imaging using Quantitative Fluorescence Endoscopy in locally advanced esophageal cancer using durvalumab-680LT: a phase I multicenter feasibility and safety study

Recruiting

Conditions: Locally advanced esophageal cancer
10017990

Registration Number: NL-OMON51996

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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

- 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;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the safety and feasibility of quantitative fluorescence endoscopy<br /><br>using the fluorescent tracer durvalumab-680LT to get more insight in the<br /><br>heterogeneity of programmed death-1 ligand (PD-L1) expression before and after<br /><br>neoadjuvant therapy in patients with locally advanced EC.</p><br>

Secondary Outcome Measures