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

NCT04554771 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-07-29

No results posted yet for this study

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.

Conditions

  • Esophageal Adenocarcinoma
  • Oesophageal Adenocarcinoma
  • Resectable Carcinoma

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

Sponsors & Collaborators

  • Noordwest Ziekenhuisgroep

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Hanneke WM van Laarhoven, MD, PhD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2022-10-10
Completion
2028-04-10

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04554771 on ClinicalTrials.gov