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NOT YET RECRUITING
NCT07155122
PHASE2

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

Sponsor: Fujian Cancer Hospital

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Serplulimab Combined With Etoposide and Cisplatin as Neoadjuvant Therapy in Limited-Stage Small-Cell Carcinoma of the Esophageal : A Single-Arm, Phase II Clinical Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-09-01

Completion Date

2030-09-01

Last Updated

2025-09-12

Healthy Volunteers

No

Interventions

DRUG

Drug: Serplulimab

serplulimab Serplulimab , 300mg, D1, intravenous drip , Q3W.

DRUG

Drug: Etoposide

Etoposide, 60-100 mg/m², D1-3 or D1-5, intravenous drip, Q3W

DRUG

Drug: Chemotherapy

Cisplatin, 50-75 mg/m², D2, intravenous drip, Q3W. Or Carboplatin, AUC 5, D2, intravenous drip, Q3W.