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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT06894459
Eligibility Criteria:
Inclusion Criteria:
* Patients with locally advanced laryngeal and hypopharyngeal squamous cell carcinoma who have been definitively diagnosed by histology and/or cytology, and whose TN staging meets: T1-4a, N0-3.
* No prior treatment received.
* Cisplatin-tolerant.
* Age ≥18 years.
* ECOG performance status of 0-1.
* Measurable disease as defined by RECIST v1.1.
* Normal organ function.
* Women and men of reproductive potential must agree to use appropriate contraceptive methods throughout the study period and for 180 days after the last study treatment.
* Male participants must not donate sperm during the entire study period and for 180 days after the last study treatment.
Exclusion Criteria:
* T stage is T4b.
* Presence of distant metastasis.
* Received live vaccines within 30 days prior to enrollment.
* Diagnosed with an immunodeficiency or received systemic corticosteroid treatment or any other form of immunosuppressive therapy within 7 days prior to enrollment.
* Have radiologically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis.
* Have not fully recovered from surgery or from toxicities or complications due to interventions before starting the study.
* Have a history of allogeneic tissue/solid organ transplantation.
* Have had a severe hypersensitivity reaction (≥Grade 3) to PD-1 inhibitors, chemotherapy, or any of their excipients, or radiotherapy.
* Have an active autoimmune disease that has required systemic therapy within the past 2 years.
* Have a history of (non-infectious) pneumonitis that required treatment with corticosteroids.
* Have a history of infection with the Human Immunodeficiency Virus (HIV).
* Have a medical history that could confound study results or interfere with the participant during the study period.
* Have a known history of psychiatric disorders or substance abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06894459
Study Brief:
Protocol Section:
NCT06894459