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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT07133958
Eligibility Criteria:
Inclusion Criteria:
1. Oral squamous cell carcinoma or oropharyngeal squamous cell carcinoma diagnosed as locally advanced (T3-4) according to the AJCC criteria
2. Their age ranged from 18 to 80 years
3. There was no history of other malignant tumors or treatment
4. Adequate blood function: white blood cell count (WBC) ≥3.5×10\^9/L, platelet count (PLT) ≥75×10\^9/L; Hemoglobin concentration (HGB) ≥90g/L
5. Adequate liver function: total bilirubin (TBIL) ≤ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal
6. "Adequate renal function: urinary white blood cells \< 10, red blood cells \< 10, cast count \< 5 per high-power field, and creatinine (CRE) ≤ the upper limit of normal.
7. The heart, brain, lung and other vital organs function and general condition can tolerate NACI and surgical treatment
8. PS score ≤2
Exclusion Criteria:
1. Presence of distant metastasis
2. Women who are pregnant or lactating
3. Patients who are unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons
4. Receiving investigational treatment in addition to other clinical studies (in the treatment phase of a clinical study)
5. Accompanied by severe uncontrolled infection or medical illness
6. Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, cannot tolerate NACI or surgical treatment
7. There are factors affecting surgery or anesthesia, such as severe organ dysfunction
8. Long-term use of immunosuppressive agents after organ transplantation
9. Patients with a history of other malignant tumors before enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07133958
Study Brief:
Protocol Section:
NCT07133958