Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
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.
Interventions
DRUGNivolumab
Nivolumab
Sponsors
Ono Pharmaceutical Co. Ltd
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed esophageal squamous cell carcinoma 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
1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major pathologic response | 2 months | Viable tumor comprised ≤ 10% of resected tumor specimens |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 2 months | Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions |
| Positron Emission Tomography (PET)-CT response | 2 months | Complete metabolic response is defined as the SUV of 2.5 or less than 2.5 of primary tumor |
| Progression-free survival (PFS) | 24 months | Time from the enrollment to disease relapse after complete resection or death from any cause |
| Overall survival (OS) | 24 months | Time from the enrollment to death of any cause |
Countries
South Korea
Contacts
Primary ContactJong-Mu Sun, Ph.D, MD
Outcome results
None listed