At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed esophageal squamous cell carcinoma
- ✓R0 resectable thoracic esophageal cancer, cT1-3N1-2M0 or cT2-3N0M0 (AJCC V8)
- ✓No suspicious metastatic lymph nodes on the clavicle
- ✓Age 18-75 years old
- ✕Ineligible or contraindicated for esophagectomy
- ✕Prior therapy for esophageal cancer
- ✕Active autoimmune disease or history of autoimmune disease
- ✕Requiring systemic corticosteroids or other immunosuppressive medications
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04807673Phase 3RecruitingUpdate OverdueUpdated 49mo ago · Completion was 30mo agoA Multicenter Randomized, Controlled Phase III Clinical Trial of Pembrolizumab Plus Paclitaxel and Cisplatin Versus Neoadjuvant Chemoradiotherapy Followed by Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (KEYSTONE-002)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Paclitaxel, and 2 other interventions for Esophageal Squamous Cell Carcinoma. Currently recruiting, targeting 342 participants across 1 site.
Signals
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus paclitaxel, cisplatin as neoadjuvant therapy followed by surgery, and pembrolizumab as adjuvant therapy, compared with neoadjuvant chemoradiotherapy and surgery for locally advanced ESCC in multicenter.
Study Details
Timeline
Interventions
Neoadjuvant period: pembrolizumab 200mg IV D1, Q3W, and preoperative therapy with three cycles. Adjuvant period: pembrolizumab 200 mg IV D1, Q3W, up to one year, which should be performed within 3-6 weeks after surgery.
Neoadjuvant period: paclitaxel 135mg/m\^2 IV on Day 2 Q3W, and a total of three cycles.
Neoadjuvant period: cisplatin 80 mg/m\^2 IV on Day 2 Q3W, and a total of three cycles.
neoadjuvant chemoradiotherapy 41.4Gy(1.8Gy×23 fractions) with five cycles of TP(Paclitaxel 50mg/m\^2 on D1 and Cisplatin 25mg/m\^2 D1, repeated every week