Neoadjuvant Nivolumab for Operable Esophageal Carcinoma
NCT ID: NCT03987815
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2019-08-01
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study Arm
Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles
Nivolumab
Nivolumab
Interventions
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Nivolumab
Nivolumab
Eligibility Criteria
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Inclusion Criteria
2. Clinical stage T2N0 (invasion to muscularis propria) or T3N0 (invasion to adventitia)
3. ECOG performance 0 or 1
4. Age 19 years or older
Exclusion Criteria
2. Ineligibility or contraindication for esophagectomy
3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
5. Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.
19 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Samsung Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jong-Mu Sun
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Jong-Mu Sun
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jong-Mu Sun
Role: primary
Other Identifiers
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2019-01-147-0004
Identifier Type: -
Identifier Source: org_study_id