NCT05450484CompletedPhase 1
Quantitative Fluorescence Endoscopy Using Durvalumab-680LT in Esophageal Cancer
Optical PD-L1 Imaging Using Quantitative Fluorescence Endoscopy in Locally Advanced Esophageal Cancer Using Durvalumab-680LT: a Multicenter Feasibility and Safety Study
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
Treatment of patients with locally advanced esophageal cancer (EC) is multidisciplinary and consists of neoadjuvant therapy followed by surgical removal of the esophageal tumor and potentially tumor positive lymph nodes. The beneficial effect of the addition of immunotherapy to improve response rates to current treatment strategies has been investigated response to, since only 16 to 43% of EC patients achieve a pathological complete response (pCR) after neoadjuvant therapy and a pCR is associated with better long-term outcomes. Unfortunately, not all patients respond to immunotherapy and the knowledge about biomarkers that predict response to therapy are required. A promising novel parameter is tumor programmed death-ligand 1 (PD-L1) expression, one of the immune checkpoints targeted by cancer immunotherapy. Studies performed in patients with various solid tumors demonstrate improved response to immunotherapy and survival benefit in patients with higher PD-L1 expression. Nonetheless, not all patients with high PD-L1 expression show benefit and some without expression do. Moreover, mostly biopsy-based tests are used to assess PD-L1 status, although these tests are prone to errors, partly due to heterogeneity in tissue expression. Novel methods are needed to gain more insight in the PD-L1 expression in order to better select patients who are likely to benefit from immunotherapy. The investigators hypothesize that quantitative fluorescence endoscopy using the tracer durvalumab-680LT targeting PD-L1 is a promising technique to investigate the heterogeneity of PD-L1 expression.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 13 Jun 2022
- Start date
- 5 Apr 2023
- Primary completion date
- 25 Nov 2024
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05450484
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 21
- From 5 Apr 2023 to the primary completion date, 25 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent uncontrolled medical conditions according to treating medical physician;
- 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 dose of durvalumab-680LT according to the patient's medical history;
Other illness
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician;
- Medical history of auto-immune disease
- History of infusion reactions to durvalumab or other monoclonal antibodies according to the patient's medical history;
Other
- 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);
Who the study is looking for
- Lesion suspected for locally advanced EC (cT1b-4a N0-3 M0)
- Indication for neoadjuvant therapy
- Age ≥ 18 years;
- Written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.