NCT02844075

Preoperative Chemoradiotherapy and MK-3475 for Esophageal Squamous Cell Carcinoma (ACTS-29)

A Phase II Trial of Preoperative Chemoradiotherapy and MK-3475 for Esophageal Squamous Cell Carcinoma (ACTS-29)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	MK-3475(pembrolizumab)	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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2021-03-09
• Completion: 2021-04-26
• First posted: 2016-07-26
• Last updated: 2024-11-15
• Results posted: 2024-11-15

Locations

1 site across 1 country: South Korea