NCT07155122
Efficacy and Safety of Serplulimab Combined With Etoposide and Cisplatin as Neoadjuvant Therapy in Limited-Stage Small-Cell Carcinoma of the Esophageal
Not Yet Recruiting · Phase 2 · Fujian Cancer Hospital · registry updated 2025-09-12
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Male or female patients aged ≥18 years;
- Histologically or cytologically confirmed diagnosis of SCCE prior to initiation of any treatment;
- Clinical stage cT2-4aNxM0 or cT1N+M0, corresponding to limited-stage SCCE based on the American Joint Committee on Cancer (AJCC) staging systemand the Veterans Administration Lung Study Group (VALSG) classification for small cell lung cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- For women of childbearing potential, a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L or equivalent) within 48 hours prior to the first administration of the study drug. Female patients must not be breastfeeding;
- All participants were required to undergo baseline laboratory evaluations within two weeks prior to treatment, and the results must meet the following criteria (based on CTCAE version 5.0):White blood cell count ≥ 3,000/μL; Absolute neutrophil count ≥ 1,500/μL; Platelet count ≥ 75 × 10³/μL; Hemoglobin ≥ 9.0 g/dL; Creatinine clearance \> 30 mL/min (calculated by the Cockcroft-Gault formula); Aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 3 × ULN; Total bilirubin ≤ 1.5 × ULN.
Exclusion
- Patients with esophageal cancer of any histological type other than small cell carcinoma;
- Patients clinically staged as cT4bNanyM0, cTanyN3M0, or cTanyNanyM1;
- History of other malignancies, unless the patient has achieved complete remission for at least 3 years prior to enrollment and does not require or is not expected to require additional treatment during the study period;
- Known or suspected active autoimmune diseases. However, patients with type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger may be included;
- Systemic treatment with corticosteroids (\>10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to administration of study drugs. Inhaled, topical, or adrenal replacement corticosteroids at doses \>10 mg/day of prednisone equivalent are permitted in the absence of active autoimmune disease;
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or any other agents targeting T-cell co-stimulatory or immune checkpoint pathways;