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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT07137858
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 75 years old;
2. According to the 8th edition guidelines of the American Joint Committee on Cancer (AJCC), patients with pathologically confirmed head and neck squamous cell carcinoma (oral cavity including cheek, tongue, gum, floor of mouth, palate, maxillary sinus), and having stage III-IVB tumors other than oropharyngeal cancer;
3. Before enrollment, the resectable tumors were evaluated by head and neck surgeons, and clinical evidence of distant metastasis was excluded;
4. According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, at least one measurable tumor lesion was present;
5. The performance status of the Eastern Cooperative Oncology Group (ECOG) was 0-1;
6. Blood routine: White blood cell count (WBC) ≥ 3.0×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet (PLT) ≥ 100×109/L; Hemoglobin level (HGB) ≥ 9.0 g/dL (without corresponding supportive treatments such as blood transfusion and increase in white blood cells within 7 days);
7. Liver function: For patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); Albumin (ALB) ≥ 30 g/L;
8. Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate (CrCl) ≥ 50 mL/min (using the Cockcroft/Gault formula); Urinary protein (UPRO) \< (++), or 24-hour urine protein quantity \< 1.0 gram;
9. HPV status of oropharyngeal cancer was determined by p16 IHC. If more than 70% of tumor cells showed strong diffuse nuclear and cytoplasmic staining, the sample was considered p16 positive;
10. Within the past 30 days, no other clinical trial projects were participated in;
11. Patients who voluntarily participated in this project and signed the informed consent form.
Exclusion Criteria:
1. The patient's blood indicators were abnormal, and their liver and kidney functions were also abnormal. After a multidisciplinary consultation, it was determined that they could not tolerate the process of this clinical study.
2. The patient had previously suffered from tumors in other parts of the body, or had undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy in the past.
3. Due to personal, social, or economic reasons, they were unable to complete the entire clinical study process.
4. The patient had previously suffered from severe systemic diseases that could not be cured or controlled by medication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07137858
Study Brief:
Protocol Section:
NCT07137858