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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT06848920
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed newly diagnosed or recurrent locally advanced (T4N1M0) differentiated thyroid carcinoma with an estimated risk of R2 resection.
Performance Status (PS) score of 0-1. Age ≥ 18 years. Measurable lesions according to RECIST 1.1 criteria. Normal function of major organ systems.
Exclusion Criteria:
* Intratracheal airway tumors. Complete carotid artery encasement/invasion. Full-thickness infiltration of the esophageal wall. Arterial thrombosis/cancer thrombus. Active hemoptysis (bright red blood ≥ 1/2 teaspoon) or other uncontrolled bleeding within 21 days prior to study enrollment.
History of prior neck radiotherapy. Previous treatment with Lenvatinib or immunotherapy. Participants with \> 1+ proteinuria on urine dipstick will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥ 1g/24 hours will be ineligible.
Active, known, or suspected autoimmune diseases. Participants requiring long-term systemic corticosteroid therapy. Participants using bronchodilators, inhaled corticosteroids intermittently due to COPD or asthma, or those receiving local corticosteroid injections may be eligible.
Active unstable angina and/or congestive heart failure. New-onset myocardial infarction within the last 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06848920
Study Brief:
Protocol Section:
NCT06848920