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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
serplulimab Serplulimab , 300mg, D1, intravenous drip , Q3W.
Etoposide, 60-100 mg/m², D1-3 or D1-5, intravenous drip, Q3W
Cisplatin, 50-75 mg/m², D2, intravenous drip, Q3W. Or Carboplatin, AUC 5, D2, intravenous drip, Q3W.
pathological complete response rate (pCR)
Time frame: Each 2 cycles (each cycle is 21 days).
Major pathological response rate (MPR)
Time frame: Each 2 cycles (each cycle is 21 days).
Objective response rate (ORR)
Time frame: Each 2 cycles (each cycle is 21 days).
Disease control rate (DCR)
Time frame: Each 2 cycles (each cycle is 21 days).
Disease-free survival (DFS)
Time frame: 36-months
Overall survival (OS)
Time frame: 36-months
Safety: The incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time frame: From the time the subject is enrolled until the 90th day after the last dose
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