Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
Recruiting now · Phase 2
Conditions studied: Esophageal Squamous Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT06601309
- Run by
- Fujian Medical University Union Hospital
- People needed
- 90
- Starts
- 2024-07-11
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-09-15
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)
Full record on ClinicalTrials.gov
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