Adjuvant Durvalumab for Esophageal Cancer

Sponsor
Samsung Medical Center
Study ID
NCT02520453
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Adjuvant Durvalumab vs Placebo for 1 year after complete resection of esophageal cancer following neoadjuvant CCRT.

Key Dates

Start date
Feb 29, 2016
Status verified
Dec 2019
Primary completion
Jun 30, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
86 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab
    Durvalumab 20 mg/Kg IV Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
  • Placebo Comparator: Placebo
    Placebo Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity

Primary Outcome Measure

Disease-free survival [ Time Frame: 1 year ]

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