NCT07155122

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Small cell carcinoma of the esophagus (SCCE) is a rare but highly aggressive subtype of esophageal cancer, accounting for approximately 0.4% to 2.8% of all esophageal malignancies. It is characterized by high malignancy, a strong tendency for early metastasis, and poor prognosis. Currently, there is no standardized treatment regimen for SCCE. The efficacy of chemotherapy is limited, and resistance often develops rapidly. With the advancement of cancer immunotherapy, PD-1/PD-L1 inhibitors have demonstrated significant efficacy across various solid tumors. Given the biological and molecular similarities between SCCE and small cell lung cancer (SCLC), immune checkpoint inhibitors may offer a novel therapeutic avenue for patients with SCCE.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 preoperative neoadjuvant treatment drugs are f serplulimab + etoposide + platinum, with a cycle of 3 weeks. The combined treatment is given for 2 cycles. Radical resection of esophageal cancer is performed 4 to 6 weeks after the last dose. After surgery, the researcher decides whether to continue adjuvant treatment based on the pathological condition.

Conditions

• Small-Cell Carcinoma of the Esophageal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2030-09-01
• First posted: 2025-09-04
• Last updated: 2025-09-12