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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT06714266
Eligibility Criteria:
Inclusion Criteria:
* 1\. Written informed consent was obtained before enrollment.
* 2\. Age ≥18 years old, both male and female;
* 3\. Recurrent or metastatic head and neck squamous cell carcinoma without prior systemic therapy;
* 4\. the presence of at least one measurable lesion;
* 5\. ECOG PS = 0-1;
* 6\. Expected survival time ≥ 3 months
* 7\. Laboratory tests meet the following standards: Hemoglobin ≥ 100 g/L (female), 110g/L (male) Neutrophil count ≥ 2×109/L Platelet count ≥100×109/L; Creatinine ≤ 15mg/L or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); Total bilirubin ≤ 1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or ≤5× ULN (in patients with liver metastases); Albumin ≥ 30 g/L;
* 8\. Women: all women of childbearing potential must have a negative serum pregnancy test during the screening period and must be using a reliable contraceptive method from the time of informed consent until 3 months after the last dose;
Exclusion Criteria:
* 1\. Patients with known allergies to any of the drugs in the study;
* 2\. Participated in other drug clinical trials within 4 weeks before the study;
* 3\. a history of major bleeding, with any bleeding event of CTCAE4.0 grade 3 or above within 4 weeks before screening;
* 4\. patients with hypertension that is not well controlled by single antihypertensive medication (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg); 8. Clinically significant (e.g., active) cardiovascular disease - e.g., cerebrovascular accident (≤ 6 months before randomization), myocardial infarction (≤ 6 months before randomization), unstable angina, congestive heart failure of New York Heart Association (NYHA) class II or higher, or severe arrhythmias that could not be controlled with medications or that could potentially affect trial treatment;
* 5\. Previous arterial/venous thrombosis events occurred within 6 months before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization due to previous chemotherapy, which was judged by the investigator to be cured), and pulmonary embolism;
* 6\. Renal insufficiency: urine routine proteinuria \> 2+ and confirmed 24-hour urinary protein quantitation \> 1.0 g;
* 7\. Symptomatic brain metastases (proven or suspected);
* 8\. Presence of severe or uncontrolled infection;
* 9\. Those who have a history of psychotropic drug abuse and cannot be abstinent or have a history of mental disorder;
* 10\. A history of immunodeficiency, including testing positive for HIV, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation; He had a history of autoimmune diseases.
* 11\. Use of high-dose glucocorticoids for 4 weeks.
* 12\. Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of pulmonary function, etc.;
* 13\. Concomitant medical conditions that, in the investigator's judgment, seriously compromise patient safety or interfere with patient completion of the study. He had received a previous hematopoietic stem-cell or bone marrow transplant
* 14\. Allergy to the study drug or its components;
* 15\. Those who were deemed unsuitable for the study by the investigator.
* 16\. Electrolyte disorder, low calcium, low potassium, low phosphorus.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06714266
Study Brief:
Protocol Section:
NCT06714266