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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT06563869
Eligibility Criteria:
Inclusion Criteria:
1. Voluntary signing of informed consent;
2. Male or female, aged 18 years or above and 75 years or below;
3. Patients diagnosed with esophageal squamous cell carcinoma by biopsy histopathological examination of the primary lesion; cervical metastasis was excluded by cervical B-ultrasound.
4. Patients who were judged by imaging and endoscopic ultrasound examination to have potentially surgically resectable middle and lower esophagus (below 18 cm from the incisors) and require neoadjuvant therapy (T2-4aNxM0, stage II-IVA); for T2N0M0, the length of the primary tumor under endoscopic examination was required to be ≥ 2 cm, located below the neck, and ≥ 5 cm away from the cricopharyngeal muscle.
5. Patients have not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.;
6. The ECOG performance status score is 0-1;
7. Have adequate heart, lung, liver and kidney functions, and the laboratory tests within 14 days before screening meet the following indicators:
i. Hemoglobin HB ≥ 90 g/L ii. Absolute neutrophil count ANC ≥ 1.5 × 109 /L iii. Platelet count PLT ≥ 80 × 109 /L iv. Albumin ALB ≥ 35 g/L v. Alanine aminotransferase ALT and aspartate aminotransferase AST ≤ 1.5 times the upper limit of the normal range vi. Total bilirubin ≤ 30 μmol/L vii. Creatinine SCr ≤ the upper limit of the normal range. viii. Coagulation: PT-INR ≤ 2.3 or PT \< 6 seconds compared with the normal control
8. Patients need to be able to complete the treatment and follow-up according to the research plan on schedule;
9. Patients need to have sufficient tissue samples and agree to use their tissue samples and blood samples for research analysis;
10. Pregnancy tests in women of childbearing age were negative and were willing to take effective contraceptive measures during the study.
Exclusion Criteria:
1. Patients who may have tracheoesophageal fistula or aortic esophageal fistula;
2. Patients with severe malnutrition or in need of tube feeding;
3. Patients with other malignant tumors within 2 years and not cured (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ);
4. Patients with active autoimmune system diseases, or with a history of autoimmune system diseases or symptoms and in need of systemic hormone therapy or anti-autoimmune drug therapy;
5. Patients with immunodeficiency, or still receiving systemic steroid hormone therapy (prednisone \> 10 mg/day or other equivalent drugs) 7 days before the administration of the first dose of neoadjuvant therapy in this study, or other forms of immunosuppressive therapy;
6. Patients with active infection and still in need of systemic treatment 7 days before the administration of the first dose of neoadjuvant therapy in this study;
7. Patients with uncontrollable systemic diabetes;
8. Patients with interstitial lung disease, non-infectious pneumonia or pulmonary fibrosis;
9. Patients with previous motor nerve or sensory nerve toxicity symptoms greater than WHO grade 1;
10. Patients who have received allogeneic organ or stem cell transplantation in the past;
11. Patients allergic to the drugs or related components involved in this study;
12. Patients currently participating in other clinical studies;
13. Patients who received anti-programmed death-1 (PD-1)/PD-1 ligand (PD-L1) monoclonal antibodies, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies or other immune or molecular targeted therapies within 4 weeks before screening;
14. Patients with any serious or unstable medical conditions or mental illnesses;
15. Patients with known active alcohol or drug abuse or dependence.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06563869
Study Brief:
Protocol Section:
NCT06563869