Actively Recruiting
Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
Led by Fujian Medical University Union Hospital · Updated on 2025-09-15
90
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed esophageal squamous cell carcinoma (ESCC)
- Resectable locally advanced ESCC (clinical stage II-III per AJCC/UICC 8th edition)
- Age between 18 and 75 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Available PD-L1 expression level (CPS)
- Eligible for surgical resection as assessed by a thoracic surgeon
- Adequate bone marrow function: Absolute neutrophil count 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
- Ability to understand and willingness to sign written informed consent
You will not qualify if you...
- Presence of distant metastasis
- History of other malignancies within past 5 years except treated carcinoma in situ of cervix, basal or squamous cell skin carcinoma, or localized non-invasive malignancy
- History of active autoimmune diseases requiring systemic treatment within past 2 years
- Active infection requiring systemic therapy
- Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness/social situations limiting compliance
- Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
- Pregnant or breastfeeding women; women of childbearing potential must have negative serum pregnancy test within 7 days prior to randomization
- Known allergy or hypersensitivity to study drugs or their excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
Z
Zhao-han Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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