drugset / Trial / NCT07155122

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

NCT07155122

Phase 2 Not yet recruiting 15 enrolled Fujian Cancer Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-09-01
Primary completion
2027-09-01
Completion
2030-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Cisplatin Other / unclassified 50 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Etoposide Small molecule 60 mg/m2 Intravenous
Subject Etoposide Small molecule 100 mg/m2 Intravenous
Subject Serplulimab Monoclonal antibody 300 mg Intravenous