NCT03322267

Adjuvant Pembrolizumab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma at High Risk of Recurrence

A Single-arm Phase II Study of Chemoradiotherapy Plus Pembrolizumab as Adjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma Patients at High Risk of Recurrence Following Preoperative Chemoradiotherapy Plus Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

In this study, participants with histologically diagnosed locally advanced esophageal squamous cell carcinoma who have received preoperative cisplatin-based chemoradiotherapy followed by surgery harbouring high risk of tumor recurrence will receive adjuvant cisplatin-based chemoradiotherapy followed by pembrolizumab. The primary study hypothesis is that adjuvant pembrolizumab will improve the 1-year recurrence-free survival rate compared to historical control.

Detailed description

It is a single-arm phase II trial. The target population is patients with histologically diagnosed locally advanced ESCC patients (clinically staged at least T3 and/or any N and M0 by endoscopic ultrasonography \[EUS\] and fludeoxyglucose-positron emission tomography \[FDG-PET\]) who have received preoperative cisplatin-based chemoradiotherapy (CRT) followed by surgery, and exhibit high risk (closed or involved resection margin or extranodal invasion of involved lymph nodes or ypN2-3) of tumor recurrence. Eligible patients will receive adjuvant cisplatin-based CRT followed by pembrolizumab for 18 cycles.The study will enroll 46 patients in Taiwan. The estimated enrollment period is 2 years.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Cisplatin (30 mg/m2, QW, 2 cycles) and radiotherapy (18-26 Gy/10-13 fractions) as adjuvant chemoradiotherapy, followed by pembrolizumab (200mg, Q3W, 18 cycles)

Timeline

• Start date: 2018-10-27
• Primary completion: 2024-01-31
• Completion: 2026-01-30
• First posted: 2017-10-26
• Last updated: 2026-03-06
• Results posted: 2024-12-19

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study