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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT06388135
Eligibility Criteria:
Inclusion criteria:
* The age range of the enrolled patients was 18-70 years;
* ECOG score 0-1 ;
* Patients with ESCC diagnosed by pathology (histology or cytology);
* Resectable IB-III (cT1b\~3N1-2M0 or cT3\~4aN0\~1M0) stage per the 8th edition of clinical TNM staging;
* Measurable lesions (per RECIST 1.1 criteria: major tumor diameter on CT scan ≥10mm, short lymph node diameter on CT scan ≥15mm);
* No prior radiotherapy, chemotherapy, surgery, or targeted therapy;
* Surgical tolerance and ability to consume liquid diet without esophageal complications;
* Normal major organ function criteria: (1) Blood tests: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L, HB ≥ 90 g/L; (2) Biochemical tests: TBIL≤1.5×ULN, ALT/AST≤ 2.5×ULN, serum creatinine ≤1.5×ULN, ALB ≥ 30 g/L; (3) Coagulation function: INR≤1.5×ULN, APTT≤1.5×ULN;
* Normal or mildly to moderately abnormal lung function suitable for EC surgery: A) VC%\>60%, B) FEV1\>1.2L, FEV1%\>40%, C) DLCO\>40%;
* Voluntary participation with informed consent and good compliance.
The exclusion criteria were as follows:
* Any current or past presence of autoimmune diseases;
* Patients with immune deficiency disorders like HIV infection, active hepatitis B (HBV DNA ≥ 500 IU/ML), hepatitis C (HCV antibody positive, and HCV-RNA above the detection limit), or co-infection with hepatitis B and hepatitis C;
* Patients who have taken immunosuppressive drugs within 14 days before enrollment; patients who experienced a weight loss of ≥10% within 6 months prior to enrollment, or have a BMI below 18.5kg/m2, or have a PG-SGA score indicating grade C;
* Patients who had attenuated live vaccines within 4 weeks before enrollment;
* History of other cancers;
* Patients with myocardial infarction within six months before enrollment or diagnosed with New York Heart Association grade ≥ II heart failure;
* Patients who have experienced severe infections or undergone allogeneic organ transplantation or hematopoietic stem cell transplantation within the 4 weeks preceding enrollment;
* Patients with substance abuse, alcohol consumption, or psychotropic substance use.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06388135
Study Brief:
Protocol Section:
NCT06388135