Status:
RECRUITING
Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
Lead Sponsor:
Fujian Medical University Union Hospital
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Detailed Description
Esophageal cancer is a malignant tumor with a high incidence in China, with most patients diagnosed at the advanced stage. Traditional treatment modalities include surgery, chemoradiotherapy, and chem...
Eligibility Criteria
Inclusion
- Diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC).
- Stage: Resectable locally advanced ESCC (clinical stage II-III according to the AJCC/UICC 8th edition).
- Age: 18-75 years old.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- PD-L1 Expression: Available PD-L1 expression level (CPS).
- Surgical Eligibility: Assessed as eligible for surgical resection by a thoracic surgeon.
- 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.
- Informed Consent: Ability to understand and willingness to sign a written informed consent document.
Exclusion
- Distant Metastasis: Presence of distant metastasis.
- 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.
- Autoimmune Diseases: History of active autoimmune diseases requiring systemic treatment within the past 2 years.
- Infections: Active infection requiring systemic therapy.
- 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.
- Previous Treatment: Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
- Pregnancy and Lactation: Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
- Allergies: Known allergy or hypersensitivity to study drugs or any excipient of these medications.
Key Trial Info
Start Date :
July 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06601309
Start Date
July 11 2024
End Date
December 1 2026
Last Update
September 15 2025
Active Locations (1)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001