Clinical Trial

Efficacy and Safety of Serplulimab Combined With Etoposide and Cisplatin as Neoadjuvant Therapy in Limited-Stage Small-Cell Carcinoma of the Esophageal

Not Yet Recruiting Phase 2
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Summary
This study is a prospective, single-center, single-arm phase II clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with etoposide and platinum-based chemotherapy as neoadjuvant treatment for patients with limited-stage small cell carcinoma of the esophagus (SCCE). The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), disease control rate (DCR), disease-free survival (DFS), overall survival (OS) and safety. A total of 15 patients are expected to be enrolled.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-27.
Trial Details
NCT Number NCT07155122
Lead Sponsor Fujian Cancer Hospital
Conditions Small-Cell Carcinoma of the Esophageal
Enrollment 15 participants
Start Date 2025-09-01
Primary Completion 2027-09-01 (estimated)
Study Completion 2030-09-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-12