At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed esophageal squamous cell carcinoma (ESCC)
- ✓Clinical stage T1N1-2 or T2-34aN0-12 (AJCC 7 TNM classification)
- ✓No evidence of metastasis
- ✓ECOG performance status 0 or 1
- ✕Prior anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- ✕Active autoimmune disease requiring systemic treatment in past 2 years
- ✕Immunodeficiency or systemic immunosuppressive therapy within 7 days
- ✕Known active tuberculosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Preoperative Chemoradiotherapy and MK-3475 for Esophageal Squamous Cell Carcinoma (ACTS-29)
In Brief
A Phase 2 clinical trial evaluating MK-3475(pembrolizumab) for Esophageal Squamous Cell Carcinoma. Completed, enrolled 28 participants across 1 site.
Detailed Summary
In this study, participants with esophageal squamous cell carcinoma will receive preoperative chemoradiotherapy with paclitaxel,carboplatin and pembrolizumab then undergo surgery. The primary study hypothesis is that adding pembrolizumab will increase complete pathologic response rate at surgery.
Study Details
Timeline
Interventions
Neo-adjuvant chemoradiation period:The treatment consisted of taxol, carboplatin, pembrolizumab and radiation. The radiation treatment comprises 44.1Gy (2.1Gy/Fr, total 21Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed. Surgery:Before surgery, abdomen/chest CT scan, endoscopic ultrasound (EUS), and gastroscopy with biopsy will be done. Surgery should be done within 12 weeks after last neo-adjuvant treatment. Adjuvant period:Adjuvant treatment with pembrolizumab 200mg every 2week (maximum 2 years) should be performed within 8 weeks after surgery (recommended period : 3-6 weeks after surgery). Gastroscopy and abdomen/chest CT scan will be performed at 6 month after surgery.