Status:
NOT_YET_RECRUITING
Efficacy and Safety of Serplulimab Combined With Etoposide and Cisplatin as Neoadjuvant Therapy in Limited-Stage Small-Cell Carcinoma of the Esophageal
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Small-Cell Carcinoma of the Esophageal
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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...
Eligibility Criteria
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.
- Written informed consent must be obtained prior to the initiation of any study-related procedures. The informed consent form must be reviewed and approved by the institutional ethics committee. Participants must be willing and able to comply with the study protocol, including treatment, visit schedule, biospecimen collection, and other study-related requirements.
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;
- Any serious or uncontrolled medical conditions or active infections that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, or may interfere with the patient's ability to receive the planned treatment;
- Known history of HIV infection or acquired immunodeficiency syndrome (AIDS). (Note: HIV testing must be performed at study centers where required by local regulations);
- Clinically significant arrhythmias, myocardial ischemia, severe atrioventricular block, heart failure, or significant valvular heart disease; severe pulmonary dysfunction; hematologic, hepatic, or renal dysfunction precluding tolerance to chemoradiotherapy; severe bone marrow failure; or uncontrolled infections;
- Inability to comply with the study protocol and procedures;
- Known hypersensitivity to any component of the investigational agents used in this study.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07155122
Start Date
September 1 2025
End Date
September 1 2030
Last Update
September 12 2025
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