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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Experimental | Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Nivolumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major pathologic response | Viable tumor comprised ≤ 10% of resected tumor specimens | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions | 2 months |
| Positron Emission Tomography (PET)-CT response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong-Mu Sun, Ph.D, MD | Contact | 82-2-3410-3459 | jongmu.sun@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Jong-Mu Sun | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jong-Mu Sun | Recruiting | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Complete metabolic response is defined as the SUV of 2.5 or less than 2.5 of primary tumor
| 2 months |
| Progression-free survival (PFS) | Time from the enrollment to disease relapse after complete resection or death from any cause | 24 months |
| Overall survival (OS) | Time from the enrollment to death of any cause | 24 months |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |