Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas

NCT05745857 | Recruiting Phase 2

• 1 other identifier: 16054
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Barrett's Esophagus Without Dysplasia; Barrett Oesophagitis With Dysplasia; Esophageal Adenocarcinoma

Keywords

Fluorescence molecular endoscopy; Spectroscopy; Barrett's esophagus; Esophageal adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Feasibility of shortening qFME procedural time by oral administration of bevacizumab-800CW and cetuximab-800CW for the detection of BE neoplasia.

  Evaluating the performance of qFME with oral administration of bevacizumab-800CW and cetuximab-800CW for detection of neoplasia in BE patients compared to HD-WLE. This comparison will be based on target-to-background rations calculated from the in vivo fluorescence images and quantified by MDSFR/SFF spectroscopy measurements

  12 months

• Evaluate if the combination of tracers improves lesion detection by the number of invisible lesions detected

  Increased lesion detection in % compared to previously gathered amount of invisible lesions with topical tracer administration

  12 months

Secondary Outcomes (5)

• Collect safety data on oral administration of (combined) bevacizumab-800CW and cetuximab-800CW.

  Five minutes before and ten minutes after tracer administration

• Heart rate

  Five minutes before and ten minutes after tracer administration

• Temperature

  Five minutes before and ten minutes after tracer administration

• To (semi)quantify and evaluate the in vivo fluorescent signal of bevacizumab-800CW and cetuximab-800CW

  12 months

• Eventually further specify and objectify the improvement of qFME by standardisation

  12 months

Study Arms (3)

Oral bevacizumab-800CW

EXPERIMENTAL

Dose finding of oral bevacizumab-800CW and extend optimal dose group (n = 5 - 10)

Drug: Avastin; Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy

Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW

EXPERIMENTAL

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)

Drug: Avastin; Drug: Erbitux; Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy

Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW

EXPERIMENTAL

This arm will only be part of the study when oral administration is not feasible or safe. Compare single topical tracer administration of bevacizumab-800CW with combined topical tracer administration of bevacizumab-800CW and cetuximab-800CW. Extend combined group when lesion detection is increased or add control group with non-dysplastic BE patients if not. (n = 20)

Drug: Avastin; Drug: Erbitux; Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy

Interventions

Avastin DRUG

Orally administered

Also known as: Bevacizumab

Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW; Oral bevacizumab-800CW; Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW

Erbitux DRUG

Orally administered

Also known as: Cetuximab

Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW; Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW

Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy DEVICE

Fluorescent endoscope fiber and spectroscopy probe will be inserted through the working channel of the normal clinical therapeutic endoscope

Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW; Oral bevacizumab-800CW; Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Barrett Esophagus

Interventions

Bevacizumab; Cetuximab; Spectrum Analysis

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Wouter B. Nagengast, Prof. dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wouter B Nagengast, Prof. dr.

CONTACT

+31(0)503615755; w.b.nagengast@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1: Oral bevacizumab-800CW If oral administration is feasible the investigators will move on to arm 2, if it does not seem feasible the investigators will move on to arm 3. Arm 2: Oral cetuximab-800CW The investigators will move on to combined oral bevacizumab-800CW/cetuximab-800CW if oral cetuximab-800CW seems feasible. If it does not seem feasible, they will administer oral bevacizumab-800CW to a control group of non-dysplastic Barrett's esophagus patients. Arm 3 (only performed if oral administration does not work) Topical administration of bevacizumab-800CW compared to combined topical administration of bevacizumab-800CW/cetuximab-800CW. This group will be expanded if combined administration increases lesion detection. If this is not the case, the investigators will include a control group of non-dysplastic patients with Barrett's esophagus as a control group who will receive topical bevacizumab-800CW.

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 27, 2023
• Study Start: September 15, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)