Neoadjuvant Nivolumab for Operable Esophageal Carcinoma

Sponsor
Samsung Medical Center
Study ID
NCT03987815
Phase
PHASE2
Status
Unknown

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
Aug 1, 2019
Status verified
Dec 2019
Primary completion
Dec 31, 2021
Completion
Jul 31, 2022

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Arm
    Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles

Primary Outcome Measure

Major pathologic response [ Time Frame: 2 months ]

Central Contacts

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