Serplulimab: Serplulimab (300 mg) administered intravenously on day 1 of each 21-day cycle for 2 cycles.
Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy): Paclitaxel (175 mg/m²) and Cisplatin (75 mg/m²) administered intravenously on day 1 of each 21-day cycle for 2 cycles as part of neoadjuvant chemotherapy.
Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy): Paclitaxel (50 mg/m²) and Cisplatin (25 mg/m²) administered intravenously on days 1, 8, 15, and 22 of a 4-week cycle as part of concurrent chemoradiotherapy.
Radiotherapy: Radiotherapy at a dose of 40 Gy, delivered in 20 fractions over 4 weeks.
Study summary
This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response (pCR) rate in patients with resectable locally advanced esophageal cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC).
2. Stage: Resectable locally advanced ESCC (clinical stage II-III according to the AJCC/UICC 8th edition).
3. Age: 18-75 years old.
4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
5. PD-L1 Expression: Available PD-L1 expression level (CPS).
6. Surgical Eligibility: Assessed as eligible for surgical resection by a thoracic surgeon.
7. Laboratory Requirements:
* Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, Platelets ≥ 100 x 10\^9/L, Hemoglobin ≥ 9 g/dL.
* Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN.
* Adequate renal function: Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min.
8. Informed Consent: Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
1. Distant Metastasis: Presence of distant metastasis.
2. Other Malignancies: History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, or other localized non-invasive malignancy.
3. Autoimmune Diseases: History of active autoimmune diseases requiring systemic treatment within the past 2 years.
4. Infections: Active infection requiring systemic therapy.
5. Uncontrolled Conditions: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
6. Previous Treatment: Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
7. Pregnancy and Lactation: Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
8. Allergies: Known allergy or hypersensitivity to study drugs or any excipient of these medications.
Primary outcome measure(s)
Pathological Complete Response (pCR) Rate — after the pathological examination of surgical speciments within 14 days after the operation The proportion of patients achieving a pathological complete response (pCR) after neoadjuvant treatment and surgical resection. pCR is defined as the absence of any residual invasive cancer in the resected esophagus and all sampled lymph nodes (ypT0N0) based on hematoxylin and eosin staining.
Trial sites (1)
Facility
City
Region
Status
Fujian Medical University Union Hospital
Fuzhou
Fujian
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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