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

NCT07155122 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-09-12

No results posted yet for this study

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.

Conditions

  • Small-Cell Carcinoma of the Esophageal

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.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07155122 on ClinicalTrials.gov