Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT06907602
Eligibility Criteria:
Inclusion Criteria:
* male or female
* Age ≥ 18 years old
* Pathological confirmation of esophageal squamous cell carcinoma
* Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4 PET/CT、 Cervical, thoracic, and abdominal enhanced CT evaluation of N0 or N+
* No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a)
* Tumor longitudinal diameter ≤ 10cm
* The tumor did not involve the dentate line
* ECOG score 0 or 1
* No hematological diseases, no liver or kidney dysfunction
* Absolute neutrophil count ≥ 1.5 × 109/L
* Platelets ≥ 100 × 109/L
* Hemoglobin ≥ 11g/L
* ALT ≤ 2 times the upper limit of normal value
* TBil ≤ 1.5 times the upper limit of normal value
* Creatinine clearance rate (Cockroft) ≥ 50ml/min
* Obtain informed consent
Exclusion Criteria:
* T staging evaluation is T1/T2
* PET/CT and other evaluations show distant metastasis (M1)
* Planned pregnancy or patients during pregnancy or lactation
* History of previous chemotherapy, radiation therapy, or immunotherapy
* Previous severe coronary heart disease and heart failure (NYHA grade III/IV)
* Previous pulmonary interstitial fibrosis or severe pulmonary dysfunction that cannot tolerate surgery
* Previous autoimmune disease requiring systemic treatment within 2 years
* Previous immunodeficiency diseases or the need for systemic steroid replacement therapy
* Previous motor or sensory neurotoxic diseases
* Previous mental illness
* Potential diseases that may affect patients' ability to receive planned treatment, such as drug allergies
* Acute infectious diseases requiring systemic treatment
* Previous HIV, HBV, or HCV infections
* Previously received stem cell or solid organ transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06907602
Study Brief:
Protocol Section:
NCT06907602