CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Pembrolizumabdrug
Likely dose
Pembrolizumab 30 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03322267
NCT03322267Phase 2Completed
CompareCT.gov

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

National Taiwan University Hospital·interventional·Posted Oct 26, 2017·Updated Mar 6, 2026

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab for Esophageal Squamous Cell Carcinoma. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Squamous Cell Carcinoma
CountriesTaiwan
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 26, 2017
Enrollment StartOct 27, 2018
Primary CompletionJan 31, 2024
Study CompletionJan 30, 2026
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 8.7 years ago

Interventions

Pembrolizumabdrug

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)