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
Study ID
NCT07155122
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Small-Cell Carcinoma of the Esophageal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Drug: Serplulimab — DRUG
    serplulimab Serplulimab , 300mg, D1, intravenous drip , Q3W.
  • Drug: Etoposide — DRUG
    Etoposide, 60-100 mg/m², D1-3 or D1-5, intravenous drip, Q3W
  • Drug: Chemotherapy — DRUG
    Cisplatin, 50-75 mg/m², D2, intravenous drip, Q3W. Or Carboplatin, AUC 5, D2, intravenous drip, Q3W.

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
Sep 2025
Primary completion
Sep 1, 2027
Completion
Sep 1, 2030

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Serplulimab Combined With Etoposide and Cisplatin

Primary Outcome Measure

pathological complete response rate (pCR) [ Time Frame: Each 2 cycles (each cycle is 21 days). ]

Central Contacts