drugset / Trial / NCT03558724

Fluorescence Endoscopy of Esophageal Carcinoma

NCT03558724 ↗

Phase 1 Terminated 25 enrolled University Medical Center Groningen
Non-randomizedSingle-groupOpen-labelDiagnostic

Summary

For locally advanced esophageal cancer (EC), neoadjuvant chemoradiotherapy (nCRT) for 5 weeks followed by esophagectomy and lymphadenectomy, if necessary, is standard of care. It is reported that the pathological complete response (pCR) rate after nCRT ranges from 16% to 43%, with a median of 26.5%. According to current clinical guidelines, patients who achieved pCR still go for surgery even though those patients who achieved pCR may not benefit from surgery. Besides, about 50% of EC patients may have post-operative complications including pneumonia, anastomotic leakage, recurrent laryngeal nerve paralysis, which lead to low health-related quality of life (HQoL). The golden standard to test the pathological response is by pathological assessment of the surgical specimen and thus after surgery. Theoretically, if pCR after nCRT can be predicted accurately before surgery by advanced imaging techniques, patients could have a wait-and-see. The wait-and-see procedure includes regular follow-up and salvage surgery if recurrence is present. Therefore, molecular fluorescence endoscopy (FME) using near-infrared fluorescence (NIRF) tracer bevacizumab-800CW targeting vascular endothelial growth factor combined with high-definition white light (HD-WL) endoscopy is expected to be a promising technique to monitor pCR and fill the gap.

Timeline

Start
2018-10-29
Primary completion
2022-10-11
Completion
2022-10-11

Outcome

Outcome not reported

Stopped: “Dose-escalation was finished, but no clear correlation between fluorescence and tumor grade was established”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab-IRDye800CW Monoclonal antibody 4.5 mg Intravenous
Subject Bevacizumab-IRDye800CW Monoclonal antibody 10 mg Intravenous
Subject Bevacizumab-IRDye800CW Monoclonal antibody 25 mg Intravenous

Indications