Sequential Tegafur-gimeracil-oteracil Potassium Capsule (s-1) and Serplulimab Following Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma

Summary

This Phase II trial evaluates the efficacy and safety of Serplulimab combined with S1 chemotherapy in patients with inoperable, locally advanced esophageal squamous cell carcinoma after concurrent chemoradiation. The primary endpoint is the one-year progression-free survival rate. Secondary measures include clinical response rates, overall survival, duration of response, and safety profiles. Exploratory goals focus on the potential of biomarkers like PD-L1 and ctDNA to predict treatment outcomes. Treatment involves initial chemoradiation followed by consolidation with Serplulimab and S1, continuing for up to 12 months or until disease progression or unacceptable toxicity.

Timeline

Start

2024-05-20

Primary completion

2025-12-31

Completion

2026-04

Drugs

Indications