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Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC

NCT04550260 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2026-05-13

No results posted yet for this study

Summary

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).

Conditions

Interventions

DRUG

Durvalumab

Durvalumab intravenous infusion

DRUG

Placebo

Durvalumab matching placebo for intravenous infusion

DRUG

cisplatin + fluorouracil

cisplatin + fluorouracil, as per Standard of Care

DRUG

cisplatin + capecitabine

cisplatin + capecitabine, as per Standard of Care

RADIATION

Radiation

50-64Gy in total

Sponsors & Collaborators

Principal Investigators

  • Luhua Wang, MD · Cancer Hospital of Chinese Academy of Medical Science

  • Nabil Saba, MD · Department of Hematology and Medical Oncology, Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • China
  • France
  • Japan
  • Mexico
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT04550260 on ClinicalTrials.gov