Clinical Trial

Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Carcinoma

Recruiting Phase 1/2
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Record status
This record was last updated January 29, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
Esophageal squamous cell carcinoma is a common malignancy in China. Although neoadjuvant chemoradiotherapy followed by esophagectomy remains a standard modality for locally advanced esophageal squamous cell carcinoma, esophagectomy followed by postoperative radiotherapy is also prevalent in China. Several retrospective studies demonstrated that postoperative radiotherapy could improve the prognosis of patients. Nevertheless, there still existed approximately 11.5% and 17.2% of total patients developing local-regional relapse and hematological metastasis. The result of Checkmate 577 has shown that postoperative immunotherapy of nivolumab could improve the disease-free survival (median Disease-free Survival 29.7 mos vs. 11.0 mos). Therefore, investigators aimed to implement a pilot study to explore the safety and efficacy of combining postoperative radiotherapy and immunotherapy for patients with locally advanced esophageal squamous cell carcinoma after esophagectomy.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-07-06; most recent amendment 2025-01-26.
Status change: Not Yet Recruiting → Recruiting 2024-06-24
Trial Details
NCT Number NCT05937438
Lead Sponsor Anhui Provincial Hospital
Conditions Esophageal Carcinoma
Enrollment 70 participants
Start Date 2023-09-01
Primary Completion 2025-09-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-01-29