This is a single arm phase II study, in which maximum 3 cycles of nivolumab (240 mg fixed dose every 2 weeks) is administered for T2- or T3-node negative esophageal squamous cell carcinoma, before curative operation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Nivolumab
Jong-Mu Sun
Seoul, South Korea
RECRUITINGMajor pathologic response
Viable tumor comprised ≤ 10% of resected tumor specimens
Time frame: 2 months
Objective response rate (ORR)
Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions
Time frame: 2 months
Positron Emission Tomography (PET)-CT response
Complete metabolic response is defined as the SUV of 2.5 or less than 2.5 of primary tumor
Time frame: 2 months
Progression-free survival (PFS)
Time from the enrollment to disease relapse after complete resection or death from any cause
Time frame: 24 months
Overall survival (OS)
Time from the enrollment to death of any cause
Time frame: 24 months
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