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RICE: Radio-Immuno-Chemotherapy of Cancer of the Esophagus — RICE  

Esophageal Adenocarcinoma Clinical Trial

Official title:
A Phase II Trial to Evaluate Safety and Efficacy of Adding Durvalumab (MEDI4736) to Standard Neoadjuvant Radiochemotherapy and of Adjuvant Durvalumab +/- Tremelimumab in Locally Advanced Esophageal Adenocarcinoma and to Evaluate Biomarkers Predictive for Response to Immune Checkpoint Inhibition

Clinical Trial Summary

A phase II trial to evaluate safety and efficacy of adding durvalumab (MEDI4736) to standard neoadjuvant radiochemotherapy and of adjuvant durvalumab +/- tremelimumab in locally advanced esophageal adenocarcinoma and to evaluate biomarkers predictive for response to immune checkpoint inhibition

Clinical Trial Description

Short Study Title: RICE - Radio-Immuno-Chemotherapy of Cancer of the Esophagus Study Phase: Phase II Research hypothesis: The investigators aim at evaluating if (I) esophageal cancer is susceptible to immunotherapeutic approaches based on interference with the PD1 / PDL1 axis, if (II) treatment of locally advanced tumors by immunotherapeutic approaches increases cure rate and if (III) combination with radiotherapy is feasible and increases anti-tumor immunity. Primary Objectives: The primary objective is to evaluate safety and efficacy (measured by an increase of pathological complete response rate from 20% to 35%) of the fully human monoclonal IgG1 antibody durvalumab targeting the programmed death-ligand 1 (PD-L1) in combination with neoadjuvant radiochemotherapy, followed by surgery for locally advanced esophageal cancer and cancer of the gastric esophageal junction (GEJ). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04159974
Study type Interventional
Source University of Cologne
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 30, 2019
Completion date June 2024
View Details
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