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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT07188103
Eligibility Criteria:
Inclusion Criteria:
* a. Patients with histologically confirmed esophageal squamous cell carcinoma (ESCC) , aged 18-80 years;
* b. Unresectable locally advanced, postoperative recurrent, or metastatic ESCC that has progressed on or is intolerant to first-line systemic therapy. For patients who received definitive concurrent chemoradiotherapy (CCRT) , disease progression during or within 6 months post-treatment is considered first-line treatment failure;
* c. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) . All positive regional lymph nodes are counted as a single lesion, while non-regional metastatic lymph nodes are counted per station;
* d. Adequate major organ function, defined as:
1. Hematology:
1. Hemoglobin (Hb) ≥ 90 g/L
2. White blood cell (WBC) count ≥ 1.5 × 10⁹/L
3. Platelet count ≥ 60 × 10⁹/L
2. Serum biochemistry:
1. Albumin ≥ 25 g/L
2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN)
3. Total bilirubin ≤ 1.5 × ULN
4. Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min
3. Echocardiography:
Left ventricular ejection fraction (LVEF) ≥ 50% (lower limit of normal)
* e. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2;
* f. Expected survival ≥ 3 months;
* g. Voluntarily enrolled, with signed informed consent, and willing to comply with study protocols and follow-up.
Exclusion Criteria:
* a. Patients with severe organ dysfunction, uncontrolled acute infection, or significant comorbidities;
* b. Patients with vertebral metastases accompanied by spinal cord compression symptoms;
* c. Patients with esophagotracheal or esophagomediastinal fistulas;
* d. Patients with uncontrolled pleural, pericardial, or pelvic effusions requiring repeated drainage;
* e. Patients with esophageal primary/metastatic lesions invading the heart or great vessels, as assessed by the responsible physician, with a risk of life-threatening hemorrhage;
* f. Patients with esophageal primary/metastatic lesions invading the trachea or bronchi, as assessed by the responsible physician, with a risk of esophagotracheal fistula;
* g. Patients not suitable for short-course hypofractionated radiotherapy, as evaluated by the responsible physician;
* h. Pregnant or lactating women;
* i. Patients with mental disorders, or those with a history of psychotropic drug abuse and unable to quit;
* j. Patients who have participated in other drug clinical trials within the past 4 weeks;
* k. Patients or their families who refuse to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07188103
Study Brief:
Protocol Section:
NCT07188103