Clinical trial · Interventional
Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas
A Phase 2 Intervention Study: Detection of Early Esophageal Neoplastic Lesions by Quantified Fluorescence Molecular Endoscopy Using Oral and Topical Administration of Bevacizumab-800CW and Cetuximab-800CW
NCT05745857CI-TRIAL-00107962SLURPrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Previous studies have confirmed the great potential of quantitative fluorescence molecular endoscopy (qFME) when looking at additional lesion detection initially missed by high-definition white light endoscopy (HD-WLE) for surveillance of Barrett's esophagus.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Oesophagitis With Dysplasia | — | UNRESOLVED | — |
| Barrett's Esophagus Without Dysplasia | — | UNRESOLVED | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avastin | Drug | Bevacizumab | ALIAS |
| Erbitux | Drug | Cetuximab | ALIAS |
| Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Oral bevacizumab-800CW
- description
- Dose finding of oral bevacizumab-800CW and extend optimal dose group (n = 5 - 10)
- interventionNames
- Drug: Avastin
- Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy
- type
- EXPERIMENTAL
- label
- Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW
- description
- Dose finding of oral cetuximab-800CW in first five patients and combined oral bevacizumab-800CW and cetuximab-800CW if the investigators see good results with cetuximab-800CW. If not, they will add a control group of non-dysplastic BE patients and administer oral bevacizumab-800CW. (n = 15)
- interventionNames
- Drug: Avastin
- Drug: Erbitux
- Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * BE patients without dysplasia and with suspected/diagnosed low-grade dysplasia (LGD), high-grade dysplasia (HGD) or superficial EAC and planned diagnostic and/or therapeutic endoscopy * Written informed consent is obtained Exclusion Criteria: * Patients under the age of eighteen. * Submucosal and invasive EAC, also defined as EAC with tumor, node and metastasis (TNM)-classification other than T1. * Previous radiation therapy for esophageal cancer * Known immunoglobulin allergy * Previous chemotherapy, immunotherapy or related surgery * Prior bevacizumab or cetuximab treatment * Medical or psychiatric conditions that compromise the patient's ability to give informed consent * Pregnancy or breast feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.