Overview
The purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot radical surgery for locally advanced esophageal squamous cell carcinoma.
Description
The Preoperative chemoradiotherapy with surgery is the standard treatment in NCCN guideline. But many patients refused or abandon radiotherapy because of the intolerable adverse effects. We designed a single-arm, open-label, phase II trial of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot radical surgery for locally advanced (stage III) esophageal squamous cell cancer. The purpose of this study is to observe and evaluate the efficacy and safety.
Eligibility
Inclusion Criteria:
- Histologically confirmed esophageal squamous cell carcinoma;
- Potentially resectable cT3N1M0cT1-3N2M0(stage III);
- PD-L1(+)CPS10;
- ECOG: 0~1;
- Age 18-70 years old, both men and women.
Exclusion Criteria:
- Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer;
- Ineligibility or contraindication for esophagectomy;
- 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;
- 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);
- Has severe hypersensitivity and adverse events (Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.