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:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT04460066
Eligibility Criteria:
Key inclusion Criteria:
1. Aged 18 to 75 years old of either gender;
2. A histopathological diagnosis of esophageal squamous cell carcinoma with a clinical stage of T2N+M0 or T3-4aN+/-M0 according to the 8th edition of the UICC staging system;
3. ECOG score 0-1;
4. Estimated life expectancy \>3 months;
5. BMI ≥18.5kg/m2 or PG-SGA score A/B;
6. The function of important organs meets the following requirements:
1. white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;
2. ALT, AST and AKP ≤ 2.5×ULN;
3. serum albumin ≥ 30g/L;
4. total bilirubin ≤ 1.5×ULN;
5. serum creatinine ≤ 1.0×ULN, creatinine clearance rate ≥60 mL/min;
6. INR ≤ 1.5, PT≤ 1.5×ULN;
7. Cardiac function: ≤I, pulmonary function: FEV1 \>1.2L, FEV1% \>40%, liver function: Child-Pugh 5-6;
8. Serum HCG negative in premenopausal women ;
9. Ability to understand the study and sign informed consent.
Key exclusion Criteria:
1. Cervical esophageal carcinoma;
2. Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
3. Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of anti-PD-L1 antibody and chemotherapeutic drugs;
4. Active autoimmune diseases;
5. A history of allogeneic stem cell transplantation and organ transplantation;
6. A history of interstitial lung disease or non-infectious pneumonia;
7. Patients who cannot tolerate chemotherapy or surgery due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia;
8. A history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases;
9. Presence of active hepatitis B (HBV DNA ≥ 200 IU/mL or 103 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay);
10. A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment;
11. A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;
12. Lymph node metastasis in neck, supraclavicular, abdominal cavity, retroperitoneum and pelvic cavity (except paracardial and left gastric lymph nodes).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04460066
Study Brief:
Protocol Section:
NCT04460066