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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
Yonsei Cancer Center, Yonsei University College of Medicine
Seoul, South Korea
Complete Pathologic Response Rate
The primary endpoint of phase II study is to assess complete pathologic response rate. Definition of complete pathologic response is "no cancer cell, including lympho nodes" which corresponds with tumor regression score 0. Definition of pathologic response is as follows. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders"
Time frame: Up to 3 years
Disease Free Survival
Disease free survival is defined from the time of surgery to initial replace or death.
Time frame: Up to 3 years
Overall Survival
Overall survival is defined from the time of enrollment to death or last follow-up date.
Time frame: Up to 3 years
Pathologic Response Rate
Pathologic response rate is defined as tumor regression score. A score of '0' means 'No cancer cell, including lymph nodes'. A score of '1' means 'Single cells or small groups of cancer cells'. A score of '2' means 'Residual cancer cells outgrown by fibrosis'. A score of '3' means 'Minimum or no treatment effect'.
Time frame: Up to 3 years
Safety According to Common Terminology Criteria for Adverse Events (CTCAE) 4.03
Grade 3-4 adverse events occurring during the neoadjuvant period (no death)
Time frame: Up to 3 years
Event Free Survival
Event free survival is defined from the time of enrollment to 'event' included disease recurrence.
Time frame: Up to 3 years
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