Clinical trial · Interventional
Neoadjuvant Nivolumab for Operable Esophageal Carcinoma
Neoadjuvant Nivolumab for Operable Esophageal Squamous Cell Carcinoma
NCT03987815CI-TRIAL-00048895unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Arm
- description
- Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles
- interventionNames
- Drug: Nivolumab
Primary outcomes (1)
- measure
- Major pathologic response
- timeFrame
- 2 months
- description
- Viable tumor comprised ≤ 10% of resected tumor specimens
Secondary outcomes (4)
- measure
- Objective response rate (ORR)
- timeFrame
- 2 months
- description
- Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.