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ACTIVE NOT RECRUITING
NCT04554771
PHASE2

Blood-borne Assessment of Stromal Activation in Esophageal Adenocarcinoma to Guide Tocilizumab Therapy

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

Summary

The primary objective of this study is to demonstrate that stroma-targeting by tocilizumab in patients with adenocarcinoma of the esophagus or gastroesophageal junction with highly activated stroma increases efficacy of chemoradiotherapy measured by pathological response according to the Mandard criteria. Patients will be grouped for ADAM12, a non-invasive blood-borne marker of stromal activation.

Official title: Blood-borne Assessment of Stromal Activation in Esophageal Adenocarcinoma to Guide Tocilizumab Therapy: a Randomized Phase II Proof-of-concept Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2021-01-27

Completion Date

2028-04-10

Last Updated

2024-07-29

Healthy Volunteers

No

Interventions

DRUG

Tocilizumab 20 Mg/mL Intravenous Solution

tocilizumab 8 mg/kg with a maximum of 800 mg intravenously on day 1, 15 and 29 of standard of care neoadjuvant chemoradiation

DRUG

Paclitaxel

Paclitaxel 50 mg/m2 will be given intravenously on days 1, 8, 15, 22 and 29

DRUG

Carboplatin

Carboplatin AUC = 2 will be given intravenously on days 1, 8, 15, 22 and 29

RADIATION

External beam radiotherapy

External beam radiotherapy will be delivered to a total dose of 41.4 Gy in 23 fractions of 1.8 Gy, 5 fractions per week starting the first day of the first cycle of chemotherapy

Locations (1)

Academic Medical Center, Medical Oncology

Amsterdam, Netherlands